instructions for use - food and drug administration · 9.4.2 overview of all adverse events related...

Maestro® Rechargeable System

Instructions for Use

CAUTION: Federal Law restricts this device to sale by or on the order of a physician.

Copyright 2015 by EnteroMedics Inc., St. Paul, Minnesota

All rights reserved

EnteroMedics, VBLOC and Maestro are registered trademarks of EnteroMedics Inc.

The Maestro System is protected under U.S., European, Japanese and Australian Patents, and patent

applications.

Subject to Pat. Nos.: AU2004209978; AU2009245845; AU2006280277; AU2006280278; AU2008226689;

AU2008259917; AU2011265519; US 7,167,750; US 7,672,727; US 7,822,486; US 7,917,226;

US 8,010,204; US 8,068,918; US 8,103,349; US 8,140,167; US 8,483,830; US 8,483,838; US 8,521,299;

US 8,532,787; US 8,538,542; US 8,825,164; JP 5486588; EP 1601414; EP 1603634; EP 1922109; and

EP1922111

For use in a method covered by Pat. Nos.: AU2009231601; US 7,489,969; US 7,729,771; US 7,613,515;

US 7,844,338; US 8,046,085; US 8,538,533

Maestro® Rechargeable System P01392-001 Rev J

System Instructions for Use

© EnteroMedics, Inc 2015 of 70

Table of Contents

1. INDICATIONS FOR USE .................................................................................................................... 4

2. CONTRAINDICATIONS ..................................................................................................................... 5

3. WARNINGS ..................................................................................................................................... 6

4. PRECAUTIONS ................................................................................................................................. 8

5. DEVICE DESCRIPTION .................................................................................................................... 13

6. SYMBOLS & DEFINITIONS .............................................................................................................. 16

7. STORAGE, STERILIZATION & HANDLING ........................................................................................ 17

7.1 RE-STERILIZATION OR RE-USE OF MAESTRO RECHARGEABLE SYSTEM COMPONENTS .......................................... 18

7.2 ENVIRONMENT .................................................................................................................................... 18

8. POTENTIAL ADVERSE EVENTS ........................................................................................................ 19

9. CLINICAL STUDY ............................................................................................................................ 20

9.1 PRIMARY EFFICACY OBJECTIVES .............................................................................................................. 20

9.2 PRIMARY SAFETY OBJECTIVE .................................................................................................................. 20

9.3 SUBJECT DISPOSITION ........................................................................................................................... 20

9.4 PRIMARY SAFETY ENDPOINT ................................................................................................................... 22

9.4.1 All Serious Adverse Events ..................................................................................................... 23

9.4.2 Overview of All Adverse Events Related to Device, Therapy or Procedure ............................ 24

9.4.3 Adverse Events Leading to Study Withdrawal ....................................................................... 24

9.4.4 Surgical Removals of the Device ............................................................................................ 25

9.4.5 Surgical Revisions .................................................................................................................. 25

9.5 EFFECTIVENESS .................................................................................................................................... 25

9.5.1 Change in %EWL and %Total Body Weight Loss (%TBL) ........................................................ 26

9.5.2 Responder Analyses ............................................................................................................... 27

9.5.3 Improvements in Obesity Risk Factors ................................................................................... 27

9.6 UPDATED RESULTS THROUGH 18 MONTHS ............................................................................................... 28

10. INDIVIDUALIZATION OF TREATMENT ............................................................................................ 30

10.1 PATIENT SELECTION ......................................................................................................................... 30

10.2 USE IN SPECIFIC POPULATIONS ........................................................................................................... 30

10.3 PATIENT COUNSELING ...................................................................................................................... 30

11. OPERATING INSTRUCTIONS........................................................................................................... 31

11.1 USING THE MOBILE CHARGER ............................................................................................................ 35

11.2 MAESTRO RECHARGEABLE SYSTEM PREPARATION PRIOR TO IMPLANTATION ............................................... 37

12. IMPLANT PROCEDURE SUMMARY ................................................................................................ 41




13. LEAD STATUS (IMPEDANCE) TEST IN SURGERY .............................................................................. 44

14. DEVICE ACTIVATION AND TREATMENT INITIATION DURING SURGERY ......................................... 47

14.1 DEVICE ACTIVATION AND THERAPY INITIATION ...................................................................................... 47

14.2 POST IMPLANT HEALING PERIOD ........................................................................................................ 49

15. MODIFYING THERAPY PARAMETERS DURING FOLLOW-UP VISITS................................................. 50

15.1 FIRST FOLLOW-UP VISIT ................................................................................................................... 50

15.2 SUCCESSIVE FOLLOW-UP VISITS ......................................................................................................... 51

15.3 MAESTRO RECHARGEABLE SYSTEM REPORTS ........................................................................................ 53

16. MAINTAINING THE MAESTRO RECHARGEABLE SYSTEM ................................................................ 54

16.1 MAINTAINING THE NEUROREGULATOR ................................................................................................ 54

16.2 MAINTAINING THE MOBILE CHARGER AND TRANSMIT COIL ..................................................................... 54

17. PATIENT OPERATING INSTRUCTIONS ............................................................................................ 55

17.1 POSITIONING THE TRANSMIT COIL OVER THE NEUROREGULATOR .............................................................. 55

17.2 CHECKING NEUROREGULATOR AND MOBILE CHARGER BATTERY CHARGE LEVELS ......................................... 56

17.3 CHARGING THE BATTERY IN THE NEUROREGULATOR ............................................................................... 57

17.4 RESTORING THE MOBILE CHARGER’S DEFAULT SETTINGS ........................................................................ 58

17.5 SYSTEM ALERTS .............................................................................................................................. 58

18. DEACTIVATING THE NEUROREGULATOR ....................................................................................... 59

19. IMPLANT REMOVAL AND DISPOSAL INSTRUCTIONS ..................................................................... 60

19.1 DEVICE REMOVAL TRAINING .............................................................................................................. 60

19.2 REMOVAL OF ALL IMPLANTABLE DEVICE COMPONENTS .......................................................................... 60

19.3 REPLACEMENT OF NEUROREGULATOR ................................................................................................. 61

19.4 DEVICE DISPOSAL ............................................................................................................................ 61

20. SPECIFICATIONS ............................................................................................................................ 62

20.1 COMPONENT AND THERAPY SPECIFICATIONS ........................................................................................ 62

20.2 ELECTROMAGNETIC COMPATIBILITY TABLES .......................................................................................... 64

21. MAESTRO RECHARGEABLE SYSTEM LIMITED WARRANTY ............................................................. 68

22. CONTACT INFORMATION .............................................................................................................. 70




1. Indications for Use

The Maestro Rechargeable System is indicated for use in weight reduction in patients

aged 18 years through adulthood who have a Body Mass Index (BMI) of 40 to 45 kg/m2,

or a BMI of 35 to 39.9 kg/m2 with one or more obesity related co-morbid conditions, and

have failed at least one supervised weight management program within the past five

years.




2. Contraindications

Y Patients with cirrhosis of the liver, portal hypertension, esophageal varices or an

uncorrectable, clinically significant hiatal hernia.

Y Patients for whom magnetic resonance imaging (MRI) is planned.

Y Patients at high risk for surgical complications

Y Patients who have a permanently implanted, electrical-powered medical device or

gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators,

neurostimulators)

Y Patients for whom shortwave, microwave, or therapeutic ultrasound diathermy is

planned

Diathermy is any treatment that uses high-frequency electromagnetic radiation,

electric currents, or ultrasonic waves to produce heat in body tissues. Patients

absolutely CANNOT be treated with any type of shortwave, microwave, or

therapeutic ultrasound diathermy device whether or not it is used to produce heat.

These treatments should not be applied anywhere on the body.

.




3. Warnings

Y Certain medical therapies or procedures may cause injury to the patient,

permanent damage to the implant or may turn therapy off; particularly if used in

close proximity to the device. Therapies or procedures which may affect the

tissue/electrode interface or the neuroregulator may result in dislodgement, loss of

therapy or nerve damage. Therapies and procedures that induce current through

the lead and neuroregulator could cause nerve damage, burns, heating or pain.

These include:

Shock wave lithotripsy;

Oncologic radiation or any cobalt 60 or gamma radiation;

Mono Polar electrosurgical instruments;

Positron emission tomography (PET) scans; or

Radiofrequency ablation

Patients absolutely CANNOT be treated with any type of shortwave,

microwave, or therapeutic ultrasound diathermy device whether or not it is

used to produce heat. These treatments should not be applied anywhere on

the body. Diathermy is any treatment that uses high-frequency

electromagnetic radiation, electric currents, or ultrasonic waves to produce

heat in body tissues.

Y Patients with Twiddler’s Syndrome may move, damage or disconnect the lead

from the neuroregulator. This may interfere with therapy delivery, recharging or

may result in damage to the vagus nerves.

Y Failure to maintain adequate charge of the neuroregulator may result in additional

surgery to replace the device. The neuroregulator must be fully charged at least

once every two months. If the neuregulator is not regularly charged, the battery

may no longer be chargeable and therapy may no longer be able to be delivered.

Y If the decision is made to stop therapy, the neuroregulator must be fully charged

prior to deactivation. Verify that the neuroregulator is fully charged before it is

turned off. A deactivated neuroregulator may be turned on with clinician

programmer.

Y Lead impedance testing should only be performed using equipment approved by

EnteroMedics since leakage current could injure the patient.




Y Continued therapy with a fractured lead may result in conductor dissolution

resulting in pain, inflammation or nerve damage.

Y The Maestro System is MR Unsafe. Patients should register their implant

information with the MedicAlert Foundation (www.medicalert.org) or equivalent

organization.

Y MR is categorized as unsafe for patients in which the Maestro System was

explanted and not all components were removed.




4. Precautions

Y The safety and effectiveness of this device has not been determined for patients

under the age of 18 years

Y The Maestro Rechargeable System should only be implanted by surgeons

specifically trained to perform the Maestro Rechargeable System implant

procedure.

Y The Maestro Rechargeable System may interact with implantable devices such as

cardiac pacemakers and defibrillators, implanted spinal cord and peripheral nerve

stimulators, other neurostimulators, and body worn medical devices, such as

insulin pumps. Possible effects of the system interaction with implanted cardiac

devices include that defibrillation therapy from an implanted defibrillator may

damage the RNR. Electrical pulses from the RNR may interact with the sensing

operation of an implantable or body worn device and may result in an

inappropriate response of the device.

Y If radiation therapy is required, the area over the neuroregulator should be

shielded with lead to protect the implant from damage.

Y Maestro Rechargeable System components produce small electrical currents that

may ignite flammable liquids and gasses. Do not operate the system in flammable

environments, including flammable anesthetics.

Y Use only Maestro Rechargeable System components listed in Table 1 of this

document. Only leads listed in this table should be used with the Maestro

Rechargeable System neuroregulator.

Y Handle leads with care. Avoid stretching, kinking, or handling with surgical

instruments that may cause permanent damage to lead components including the

lead body, electrode, conductor, or connector. Do not attempt to bend or modify

the electrode during implant.

Y Maestro Rechargeable System programming should be performed only by trained

personnel under physician supervision.

Y To ensure reliable operation, the AC recharger should be not connected to a

portable multiple outlet socket or extension cord.




Y The mobile charger case may become warm during recharging of the

neuroregulator. To avoid damage to the equipment place the mobile charger in a

position that allows air circulation, do not lie in bed, sleep, sit or lie on the mobile

charger, place the mobile charger in clothing or place the mobile charger within a

carrying case.

Y To ensure reliable recharging of the neuroregulator, there must be no metal or

magnetic objects within six inches of the implanted neuroregulator and transmit

coil.

Y The mobile charger and transmit coil have limited protection from fluids and may

be damaged when immersed in liquids or used in wet environments. Patients

should not bathe, shower, or swim with the mobile charger and transmit coil.

Y Do not use any component of the Maestro System if it appears to be damaged.

Y A strong magnet, such as those found in speakers, Cathode Ray Tubes (including

television tubes), electric motors, refrigerator and freezer doors, power tools, as

well as magnets used therapeutically or worn on the body in close proximity to

the neuroregulator may inactivate the device. Patients should be cautioned to

keep such devices at least six (6) inches away from the neuroregulator. If your

device becomes inactivated because of exposure to a strong magnetic field, then

you must schedule a visit with a clinician to reactivate the neuroregulator.

Y The mobile charger should not be turned on aboard aircraft.

Y Maestro Rechargeable System components are to be returned to EnteroMedics for

safe and proper disposal. Under no circumstances should Maestro Rechargeable

System components be disposed of by incineration, including cremation.

Y The capacity of the rechargeable battery in the implanted neuroregulator will

diminish over time with use. This may require longer or more frequent charging

as the implanted neuroregulator nears the end of its useful life.

Y Electronic components of the Maestro Rechargeable System may be damaged by

therapeutic ionizing radiation; damage may not be immediately detectable.




Y The effects on device safety, operation or performance when used within a

hyperbaric chamber are unknown. Patients implanted with the Maestro

Rechargeable System should seek medical guidance prior to entering a hyperbaric

chamber.

Y Radio Frequency Identification (RFID) systems may interfere with the

communication system in your Maestro System and may result in longer charging

times and/or a not fully charged RNR battery. The clinician should be aware that

RFID systems in close proximity to the Maestro System in the clinic may result in

difficulty with interrogation and programming of the RNR. RFID sources may be

present in health care facilities, retail stores, libraries, airports and business

environments.

Y Strong magnetic fields and sources of strong electromagnetic interference

emitted from RF emitters like those emitted by electronic article surveillance

(EAS) systems, metal detectors, other security systems, lithotripsy, computer

monitors, motorized wheel chairs, x-ray equipment and other monitoring

equipment may be present in the home, work, medical, or public environments.

The effects of these RF emitters are unknown but may be strong enough to

interfere with the function of the Maestro System and may produce the following

effects:

- Serious injury; it is possible for these sources to generate enough energy in

the Maestro leads to damage the vagal nerve and surrounding tissue.

- Damage to the Maestro System; resulting in permanent loss of therapy.

- Operational changes to the RNR; turning therapy off.

Strong magnetic fields and RF emitters, including RFID systems, may not always

be visible and could result in inadvertent exposure without your awareness. You

should move away from these sources to avoid close proximity (indicated in the

table of “Recommended separation distances between portable and mobile RF

communications equipment and the Maestro Rechargeable System”) and never

recharge your RNR in the vicinity of these sources. We recommend that you turn

the RNR off, using your MC, before you enter an area with known strong

magnetic fields or EMI. If your device becomes inactivated because of exposure

to a strong magnetic field, then you must schedule a visit with a clinician to

reactivate the RNR.

The Maestro Rechargeable System may activate EAS systems, metal detectors or

other security systems. Patients should be advised not to recharge the Maestro

Rechargeable System neuroregulator and to turn the mobile charger off in the

presence of these systems.




Y Infections at the implant site have been observed, and severe infections could

require surgery and device explantation. Administration of appropriate broad-

spectrum antibiotics, as per standard of care, should be considered pre-, peri-, and

post-operative to the implant procedure.

Y Allergic reaction to the materials of the Maestro System components is possible.

Y The leads can become entangled or fractured, or the insulation can erode. Avoid

using excess lead length in the neuroregulator pocket.

Y The safety and effectiveness of defibrillation devices used on patients with the

Maestro Rechargeable system has not been established. If use of a defibrillator is

necessary, it is possible that defibrillation current may be conducted through the

leads, possibly reducing the effectiveness of the defibrillation and damaging the

nerves.

Y The safety and effectiveness of the Maestro Rechargeable System have not been

established for use during pregnancy. As soon as pregnancy has been confirmed,

the VBLOC therapy must be turned off and the neuroregulator must be fully

charged and deactivated by the clinician. Because the leads are implanted in the

abdomen, the position of the leads relative to the fetus should be monitored on a

regular basis. The Maestro Rechargeable System has not been tested with fetal

monitoring systems and may interfere with its operation.

Y Normal operating range of the neuroregulator is between 16°C (60°F) and 45°C

(113°F). Exposure to conditions which cause the temperature of the

neuroregulator to be out of this range should be avoided. This includes, but is not

limited to exposure to electric blankets, heating pads, and saunas which exceed

45°C (113°F). When exposed to temperatures outside this range while implanted,

the neuroregulator will turn off and the red status icon will be illuminated on the

mobile charger when communicating with the neuroregulator. The patient must

schedule a visit with a clinician to reactivate the neuroregulator.

Y Do not modify any of the components of the Maestro Rechargeable System.

Effects of component modification on the device safety, performance or operation

are unknown.




Y Some functions of the Maestro Rechargeable System such as

neuroregulatorbattery charging, transmit coil positioning and device interrogation

rely on a radio frequency telemetry link between the neuroregulator and mobile

charger. Interference from radio frequency transmitters in very close proximity to

the neuroregulator and mobile charger may affect these functions. Issues may be

resolved by moving to a different location where less interference is present.

Y Interference to the radio frequency telemetry link between the neuroregulator and

mobile charger may be experienced in countries outside the United States, where

frequency allocations and radio transmission parameters may differ from those in

the USA.

Y The radio frequency telemetry link between the neuroregulator and mobile

charger may stop functioning when two or more Maestro Rechargeable Systems

are operating within 10 cm of each other. The telemetry link will be re-established

and normal operation will resume when this distance is increased to greater than

10 cm.

Y Unintended access to the neuroregulator disc is prevented by the short range of

radio telemetry link and the way the neuroregulator disc and mobile charger

communicate.

Y Patients with impaired vision may not be able to successfully operate the Maestro

System.




5. Device Description

The Maestro Rechargeable System is comprised of multiple implantable and external

components. The primary components are:

Implantable components of the system include the neuroregulator and two leads.

External components of the system include a mobile charger, transmit coil, AC recharger,

and a clinician programmer.

Energy is transferred from the implanted neuroregulator to leads connected to the

patient’s anterior and posterior vagus nerves providing blocking or regulation of nerve

function. The transmit coil, when connected to the mobile charger and positioned over

the neuroregulator, is used to determine the status of the implanted device and recharge

the battery as required. The clinician programmer consists of a laptop computer with

specialized software which may be used to transmit information to, and upload data from

the neuroregulator. The data is available to the clinician to determine any changes in

treatment regimens and to monitor the performance of the Maestro Rechargable System

and patient compliance with device charging.

The system components are listed in Table 5-1:

AC Recharger

Mobile Charger Transmit Coil Rechargeable

Neuroregulator

and Leads

Clinician Programmer

and Programmer Cable




Table 5-1: Maestro Rechargeable System Components

Component Model

Number

Sterility Shelf Life Single use / Multi Use

Implantable

Components

Neuroregulator 2002 Sterile 18 months from the

date of sterile

packaging

Single Use

Posterior Lead 2200P – 47E Sterile 36 months from the

date of sterile

packaging

Single Use

Anterior Lead 2200A – 47E Sterile 36 months from the

date of sterile

packaging

Single Use

External

Components

Mobile Charger 2402 Not

Sterile

Indefinite, no shelf

life specified

**Multiple Use

(1 patient, or 1 clinician

office with multiple

patients)

Transmit Coil 2403-60 Not

Sterile


life specified

**Multiple Use

(1 patient)

AC Recharger 1620 Not

Sterile


life specified

** Multiple Use (1 patient,

or 1 clinician office with

multiple patients)

*Clinician Transmit

Coil

2403-300 Not

Sterile


life specified

** Multiple Use (1 clinician

office, multiple patients)

*Clinician

Programmer

2502 Not

Sterile


life specified



*Programmer Cable

(connects Mobile

Charger to Clinician

Programmer)

1600 Not

Sterile


life specified



Accessories

Belt for use with

2403-60 Transmit

Coil

1660 Not

Sterile


life specified

** Multiple Use (1 patient)

Torque Wrench 1680 Sterile 18 months from the

date of sterile

packaging

Single Use




Component Model

Number

Sterility Shelf Life Single use / Multi Use

Instructions for

Use

Maestro

Rechargeable

System Instructions

for Use

P01392-001

(Available on

Model 2502

Clinician

Programmer)

NA NA NA

Patient Instructions P01395-001

(Available on

Model 2502

Clinician

Programmer)

NA NA NA

Model 2502

Clinician

Programmer

Manual

P01394-001

(Available on

Model 2502

Clinician

Programmer)

NA NA NA

Surgical Implant

Procedure

P01393-001

(Available on

Model 2502

Clinician

Programmer)

NA NA NA

Easy Charge Guide P01396-001 NA NA NA

* Note: These components are not intended for use by the patient.

** Note: Reprocessing Not Required




6. Symbols & Definitions

D Do Not Reuse

I Device Sterilized by Ethylene Oxide

H Use By (Expiration Date)

M Manufacturer’s Identification

N Manufactured On (date of manufacture)

Y Caution, consult accompanying documents

i Consult the manual before use

h Catalog or reference number

g Batch Code

f Serial Number

P Authorized Representative

Type BF applied part

Defibrillation-proof Type BF applied part

Device incorporates an RF transmitter

Shipping and storage temperature range

Shipping and storage pressure range

Shipping and storage humidity range

IPX1 Protected against dripping water

Magnetic Resonance Imaging Unsafe

Length of Leads

Electrode Spacing of Leads

Trocar Size for Lead Placement




7. Storage, Sterilization & Handling

Y Store the clinician programmer and mobile charger at room temperature. Storage

temperatures must be within -10°C (14° F) or 55° C (131° F).

Y Normal operating range for the mobile charger is from 15°C (59° F) to 40°C

(108° F) and 10% to 90% relative humidity.

Y Normal operating range of the neuroregulator is between 16°C (60°F) and 45°C

(113°F). If the neuroregulatoris exposed to temperatures outside this range while

implanted, the device will turn off and the red status icon will be illuminated on

the mobile charger. If the red status icon is illuminated, the patient must schedule

a visit with a clinician during normal business hours.

Y To avoid the risk of infections or adverse reactions by the patient’s immune

system, the Maestro Rechargeable components intended for implant and the

Torque Wrench are supplied in sterile packages. Inspect the sterile package prior

to use. If the sterile package is damaged or the sterilization date has expired, do

not implant the device or components and contact EnteroMedics.

Y Do not implant a lead or neuroregulator that has been dropped or damaged after

removal from its sterile packaging. After medical adhesive has been applied to the

neuroregulator, leads should not be reinserted. Use a new neuroregulator instead.

Y The lead insulation should not be damaged. Grasp only the suture tongue and/or

the suture wing of the lead when using surgical tools. Do not tie sutures directly

around the lead. Instead use the suture fixation features provided on the lead.

Y The clinician programmer and programmer cable are not intended to be sterilized

or disinfected. The clinician programmer and programmer cable may be

periodically cleaned by wiping with a damp cloth.

Y The mobile charger and AC Recharger are not intended to be sterilized or

disinfected. The mobile charger and AC Recharger may be periodically cleaned

by wiping with damp soapy cloth.




Y The Clinician Coil and Patient Transmit Coil are not intended to be sterilized or

disinfected. The Clinician Coil and Patient Transmit Coil may be periodically

cleaned by wiping with a damp soapy cloth.

Y Patient Transmit Coil Belt may be periodically cleaned by washing by hand or

with a machine using a cold, gentle cycle and air dry.

.

Y Do not ultrasonically clean the leads or neuroregulator.

7.1 Re-sterilization or re-use of Maestro Rechargeable System components

Y Implanted components cannot be reused and are not designed to be re-sterilized.

Contact EnteroMedics for instructions regarding the return of any Maestro

Rechargeable System components. Before returning any devices that have been

exposed to patient bodily fluids, disinfect the device using a sterilant, such as

Cidex® or equivalent. Place in a sealed container with proper identification

including information regarding use of the device.

Y Re-use of a device carries the same risk as failure to sterilize since the complexity

of an active device design can provide sites of attachment for environmental

bacteria and/or small particulates. Additionally, there is the theoretical potential of

reactions by the recipient's immune system to proteins introduced as a

consequence of re-use.

Y The clinician transmit coil is not designed to be sterilized or disinfected.

7.2 Environment

Y The mobile charger and transmit coil are not designed to be waterproof. Do not

use or store the equipment in a wet or moist environment. The mobile charger is

rated as IPX1 drip proof.




8. Potential Adverse Events

Potential adverse effects (e.g., complications) associated with the implantation procedure

and/or use of the device are listed below. These adverse effects may or may not have

been observed in clinical studies and clinical use of the Maestro Rechargeable System.

Potential Adverse Events

Intra-operative Post-operative

Death

Respiratory complications

Cardiovascular complications

Bleeding

Esophageal perforation

Injury to abdominal organs (gastric perforation,

ileus, etc.)

DVT/pulmonary embolus

Electrode misplacement

Electrode malfunction

Vagal nerve injury

Esophageal erosion

Organ entrapment or strangulation

Small bowel obstruction

Vagal nerve injury

Syncope

Chest pain

Wound dehiscence

Infection

Inflammation

Bloating

Cramps

Edema

Lead malfunction

Neuroregulator malfunction

Neuroregulator migration or erosion

Electric shock

Skin reaction

Delayed gastric emptying

Gastroparesis

Dumping syndrome

Heartburn

Diarrhea

Emesis

Constipation

Eructation

Nausea

Dysphagia

Energy decrease

Alopecia

Headache

Paresthesia

Pain at the neuroregulator site

Pain

Abdominal pain

Cough

Appetite changes

Flatulence

Dyspnea

Lightheadedness/Dizziness

Gallbladder diease

Steatorrhea

Vitamin deficiency

Psychosocial malfunction




9. CLINICAL STUDY

The ReCharge Study was a randomized, double-blind, sham-controlled trial to evaluate

the safety and effectiveness of the Maestro Rechargeable System in treating obesity.

Eligible subjects were randomized in a 2:1 allocation to undergo implantation with either

an active treatment device to receive VBLOC therapy or a sham device. Subjects and

Study Coordinators were blinded until 12-month follow-up visits were completed for all

subjects, after which sham control subjects who chose to continue in the trial had the

option to have a complete Maestro Rechargeable System implanted and receive therapy.

Type 2 diabetics were limited to 10% of randomized subjects (with no more than 3

subjects per center) and once the enrollment limit was reached, the centers were notified

and type 2 diabetic enrollments were stopped.

The study was powered to assess a 20 percentage point difference in percentage Excess

Weight Loss (%EWL) between the VBLOC and sham control groups allocated in a 2:1

ratio under a “super-superiority” design. With a 10% superiority margin and an assumed

maximum 15% rate of attrition, it was determined that a minimum of 232 subjects would

be required to power the primary efficacy objective at the 85% level.

The intent-to-treat (ITT) population was the primary analysis population for this trial. If a

subject did not have primary endpoint data available at 12 months, the “last observation

carried forward” (LOCF) imputation method was applied to the missing 12-month data

points.

9.1 Primary Efficacy Objectives The first co-primary efficacy objective was to demonstrate a mean difference of at least

10% EWL between the VBLOC treatment and sham control arms (super-superiority), as

measured by the body mass index (BMI) method, at 12 months post-randomization.

A second co-primary efficacy objective was to demonstrate a responder rate in the

VBLOC treatment arm that achieved the following at 12 months:

At least 55% of treatment subjects achieved at least 20% EWL (BMI method)

At least 45% of treatment subjects achieved at least 25% EWL (BMI method)

9.2 Primary Safety Objective The primary safety objective was to demonstrate that the rate of serious adverse events

(SAEs) related to the implant/revision procedure, device, or therapy at 12 months was

less than 15% in the VBLOC group.

9.3 Subject Disposition A total of 239 subjects were randomized in the ReCharge trial. One hundred sixty-two

(162) subjects were randomized to receive a Maestro Rechargeable System (active

device) and seventy seven (77) subjects were randomized to receive the sham control

device. Two hundred and thirty-three subjects (233) were implanted (157 in the active

VBLOC arm and 76 in the sham control arm). There were 15 subjects in the type 2




diabetes mellitus cohort (9 VBLOC group, 6 sham control group). Four subjects

withdrew due to adverse events; two (1 VBLOC, 1 sham control) with pain at the

neuroregulator site, one sham control subject due to breast cancer and one sham control

subject due to anxiety. There were no withdrawals due to device malfunction. Seven

additional VBLOC subjects withdrew before 12 months. Five were prior to implant due

to the following reasons: one for discovery of cirrhotic liver at implant; three intra-

operative exlusions of Nissen fundoplication, greater than 5 cm hiatal hernia, and

extensive intra-operative dissection; and one at implant due to food discovered in the

stomach after overnight fasting. Two remaining withdrawals were due to loss to follow-

up after implant. Five additional sham subjects withdrew in the first year due to subject

decision.

Six subjects were not implanted after they were randomized. These subjects are included

in the ITT analysis.

At the 12-month visit, 89.1% of randomized subjects were available for follow-up. The

average subject was approximately 47 years of age and Caucasian (92.9%). Nearly 85%

of the subject population was female. Demographics and important baseline

characteristics are presented in the following table. No significant differences between

VBLOC and sham control subjects were observed at baseline on important demographic

characteristics.

Table 9-1: Baseline Demographic for VBLOC and Sham Control groups.

Characteristic VBLOC

N=162

Sham Control

N=77 P-value

Gender

Female 141 (87.0%) 62 (80.5%) 0.245

Male 21 (13.0%) 15 (19.5%)

Age (years) at screening 47.1 ± 10.3 46.6 ± 9.4 0.693*

Race

Caucasian 149 (92.0%) 73 (94.8%) 0.592

African American 8 (4.9%) 3 (3.9%) 1.000

Native American 2 (1.2%) 1 (1.3%) 1.000

Asian 1 (0.6%) 1 (1.3%) 0.541

Hawaiian/Pacific Islander 1 (0.6%) 0 (0.0%) 1.000

Height (m) at screening 1.7 ± 0.1 1.7 ± 0.1 0.112*

BMI at implant (kg/m2) 40.9 ± 2.8 40.9 ± 3.1 0.969*

Weight at implant (kg) 112.6 ± 13.4 115.5 ± 14.3 0.117

Excess weight (kg) at implant 43.7 ± 8.7 44.9 ± 9.5 0.371

Waist circumference (cm) at screening 121.1 ± 11.8 123.0 ± 11.3 0.236

Type 2 diabetes mellitus 9 (5.6%) 6 (7.8%) 0.571

Hypertension 63 (38.9%) 32 (41.6%) 0.920




Characteristic VBLOC

N=162

Sham Control

N=77 P-value

Dyslipidemia 91 (56.2%) 46 (59.7%) 0.884

Obstructive sleep apnea 33 (20.4%) 23 (29.9%) 0.267

Note: Data are presented as mean ± SD for continuous variables. Data are presented as n (%) for categorical variables.

P-values for continuous variables were calculated using a Student's t-test (no asterisk) or a Wilcoxon rank sum test (*)

if the variable was not normally distributed based on the Shapiro-Wilk normality test. Categorical variables were

compared using Fisher's exact test.

9.4 Primary Safety Endpoint The primary safety SAE rate (Table 9-2), defined as the proportion of subjects in the

VBLOC group who experienced an implant/revision procedure, device or therapy-related

SAE through 12 months post-implant, was 3.7% (n=6; 95% CI: 1.4% to 7.9%) in the ITT

population. This rate was significantly lower than 15% (p<0.0001), so the primary safety

endpoint was met. The type, origin, and relatedness of these SAEs are shown in Table

9-3. All SAEs were adjudicated by the Clinical Events Committee (CEC).

Table 9-2: Primary Safety Endpoint

VBLOC Group

SAE Rate (95% CI) [n/N]

P-value

(SAE Rate < 15%)

3.7% (1.4, 7.9) [6/162] <.0001

Table 9-3: Listing of Events for Primary Safety Endpoint

Subject ID SAE Type SAE Origin (Relatedness)

301-303-RC Neuroregulator malfunction Device (Definite)

301-325-RC Pain, neuroregulator site Device (Definite)

311-309-RC Atelectasis Implant/revision procedure (Definite)

311-319-RC Neuroregulator malfunction Device (Definite)

313-323-RC Gallbladder disease Therapy algorithm (Possible)

317-309-RC Emesis (Vomiting) Implant/revision procedure (Definite)

Considering all SAEs in the primary safety endpoint as well as those related to the

general surgical procedure (e.g., nausea), the rate was 8.6% (Table 9-4), which was also

significantly lower than 15%. These additional SAEs related to general surgical

procedure included 6 cases of post-operative nausea, cirrhosis (subject not implanted),

generalized ileus, and intra-operative oozing.

Table 9-4: Rate of SAEs in Primary Safety Endpoint and SAEs Related to General Surgical

Procedure




VBLOC Group

SAE Rate (95% CI) [n/N]

P-value

(SAE Rate < 15%)

8.6% (4.8, 14.1) [14/162] 0.01

9.4.1 All Serious Adverse Events

At 12 months, there were 27 SAEs among 22 VBLOC subjects (13.6%) and 4 SAEs

among 4 sham control subjects (5.2%). All SAEs are listed by CEC-determined

relatedness (Table 9-5).

Table 9-5: Serious Adverse Events by CEC Category

Serious Adverse Event

VBLOC

N=162

Sham Control

N=77

N (%) subjects N events N (%) subjects N events

SAEs related to device, implant/revision, or therapy

Neuroregulator malfunction 2 (1.2) 2 0 (0.0) 0

Atelectasis 1 (0.6) 1 0 (0.0) 0

Gallbladder disease 1 (0.6) 1 0 (0.0) 0

Emesis/vomiting 1 (0.6) 1 0 (0.0) 0

Pain, neuroregulator site 1 (0.6) 1 0 (0.0) 0

SAEs related to general surgical procedure

Nausea 6 (3.7) 6 0 (0.0) 0

Cirrhosis* 1 (0.6) 1 0 (0.0) 0

Generalized ileus 1 (0.6) 1 0 (0.0) 0

Intra-operative oozing 1 (0.6) 1 0 (0.0) 0

SAEs related to pre-existing condition or not related

Allergic reaction 1 (0.6) 1 0 (0.0) 0

Chest pain 1 (0.6) 1 0 (0.0) 0

Colitis 1 (0.6) 1 0 (0.0) 0

Gallbladder disease 1 (0.6) 1 0 (0.0) 0

Gastritis 0 (0.0) 0 1 (1.3) 1

Infection, other 1 (0.6) 1 1 (1.3) 1

Osteoarthritis 1 (0.6) 1 0 (0.0) 0

Pain, abdominal 1 (0.6) 1 0 (0.0) 0

Pain, other 2 (1.2) 2 0 (0.0) 0




Serious Adverse Event

VBLOC

N=162

Sham Control

N=77

N (%) subjects N events N (%) subjects N events

Palpitations 1 (0.6) 1 0 (0.0) 0

Pericarditis 1 (0.6) 1 0 (0.0) 0

Breast cancer 0 (0.0) 0 1 (1.3) 1

Worsening back pain 0 (0.0) 0 1 (1.3) 1

* subject not implanted

9.4.2 Overview of All Adverse Events Related to Device, Therapy or Procedure

The most common non-serious related AEs through 12 months are shown in Table 9-6.

The most common AE in both groups was pain at the neuroregulator site, although there

was no statistical difference between groups. The rates of other pain and heartburn were

statistically higher in the VBLOC group. This is not unexpected considering the

differences in surgical procedure and therapy between the treatment groups.

Table 9-6: Most Common Non-Serious Adverse Events Related to Device, Implant/Revision

Procedure, or Therapy through 12 Months among Implanted Patients

AE Type

VBLOC

N=157

Sham Control

N=76 Difference

[95% CI] N patients (%) N events N patients (%) N events

Pain, neuroregulator site 60 (38.2%) 72 32 (42.1%) 35 -3.9% [-17.5, 9.8]

Other 34 (21.7%) 43 7 (9.2%) 10 12.4% [-1.4, 25.9]

Heartburn/dyspepsia 38 (24.2%) 42 3 (3.9%) 3 20.3% [6.5, 33.5]

Pain, other 38 (24.2%) 43 0 (0.0%) 0 24.2% [10.5, 37.3]

Pain, abdominal 20 (12.7%) 26 2 (2.6%) 2 10.1% [-3.7, 23.7]

Nausea 7 (4.5%) 8 1 (1.3%) 1 3.1% [-10.5, 16.8]

Dysphagia 13 (8.3%) 13 0 (0.0%) 0 8.3% [-5.4, 21.8]

Eructation/belching 13 (8.3%) 13 0 (0.0%) 0 8.3% [-5.4, 21.8]

Chest pain 9 (5.7%) 9 2 (2.6%) 2 3.1% [-10.6, 16.8]

9.4.3 Adverse Events Leading to Study Withdrawal

There were four adverse events that led to withdrawal from the study before the 12-

month visit. In the VBLOC group, one subject (0.6%) withdrew due to pain at the

neuroregulator site. Three subjects (3.9%) in the sham control group withdrew for pain at

the neuroregulator site, anxiety, and breast cancer, respectively.




9.4.4 Surgical Removals of the Device

Five subjects (3.1%) in the VBLOC group and eight subjects (10.4%) in the sham control

group had their device explanted through the 12-month visit. In the VBLOC group, two

explants were for subject decision, one for pain at the neuroregulator site, one for pain,

other, and one for heartburn. In the sham control group, four explants were for subject

decision, one for pain at the neuroregulator site, one for a breast cancer diagnosis, one for

worsening IBS symptoms, and one in order to receive an MRI for shoulder pain. All

explanted subjects had a hospital stay of one day or less with the exception of one subject

in the sham control group who had a mastectomy at the time of explant.

An additional 16 patients in the VBLOC group had their device removed between 12 and

18 months after implant. Twelve explants were for subject decision, one for right arm

pain due to thoracic outlet syndrome, one for pain at the neuroregulator site, and two for

upper quadrant pain. An additional 9 patients in the sham control group had their device

removed between 12 and 18 months after implant. Seven explants were for subject

decision, one for need for MRI for neck and back pain, and one due to pain at the

neuroregulator site.

There were two subjects in the VBLOC group who were lost to follow-up before the 12-

month visit who did not have the device explanted.

9.4.5 Surgical Revisions

Eight subjects (4.9%) in the VBLOC arm had nine surgical revisions performed through

12 months: four for device malfunction, three for pain at the neuroregulator site, and two

for neuroregulator tilt. There were no surgical revisions in the sham control group.

9.5 Effectiveness In the ITT analysis, the VBLOC group achieved 24.4% EWL at 12 months compared to

15.9% EWL for the sham control group. The mean difference between groups was 8.5

percentage points (95% CI, 3.1 to 13.9), which was below the pre-specified super-

superiority margin of 10% (p=0.708) so the first co-primary efficacy endpoint was not

met. The VBLOC group did achieve statistically superior weight loss compared to the

sham control group as assessed by a two-sided t-test (p=0.002). In the ReCharge Study,

all patients received weight management counseling. This counseling consisted of advice

on healthy eating, being active and how to lose weight. However, patients were not

placed on prescribed diets or exercise programs. Studies have shown that weight loss

interventions (such as pharmacotherapy or other weight loss surgeries) are more effective

when they are combined with diet and exercise.

The assumptions in the design of the trial regarding the mean %EWL in the VBLOC

group (assumed 25%; observed 24.4%), as well as the standard deviation of the

difference between groups (assumed 22%, observed 21.9%) proved to be approximately

correct, however the assumption regarding %EWL in the sham control group was

underestimated by a factor of three (assumed 5%, observed 15.9%).




9.5.1 Change in %EWL and %Total Body Weight Loss (%TBL)

Figure 9-1 shows %EWL and %TBL over time without imputation. Subjects in the

VBLOC group achieved a mean of 9.8% TBL at 12 months and the sham control group

achieved 6.7% TBL.

These longitudinal data show greater weight loss with VBLOC therapy over sham control

throughout the first 12 months of the study. The mean differences between VBLOC and

sham control groups were statistically greater than zero at every visit from week 1

through 12 months, which demonstrates that the effect of VBLOC therapy was

demonstrated early and was sustained throughout the first 12 months of the trial.

Figure 9-1: Mean %EWL and %TBL and Standard Errors without Imputation




9.5.2 Responder Analyses

At 12 months in the ITT population, the VBLOC group had 52.5% of subjects with 20%

or greater EWL and 38.3% of subjects with 25% or greater EWL, which did not meet the

respective performance goals of 55% and 45%. The sham control group had 32.5% of

subjects with 20% or greater EWL and 23.4% of subjects with 25% or greater EWL.

Responder analyses were conducted comparing the percentage of subjects in each group

who achieved levels of response between 20% and 50%. As shown in Table 9-7, there is

a statistically significant treatment benefit over sham surgical control at all %EWL

thresholds from 20% EWL and above. The difference in responder rates is also presented

using odds ratios. The VBLOC group has significantly higher odds of achieving higher

%EWL thresholds over sham control at every threshold from 20% and above.

Table 9-7: %EWL Thresholds from Implant in ITT Population

%EWL Achieved VBLOC

N=162

Sham Control

N=77 OR [95% CI]

20% EWL 85 (52.5%) 25 (32.5%) 2.3 [1.3, 4.1]

25% EWL 62 (38.3%) 18 (23.4%) 2.0 [1.1, 3.8]

30% EWL 49 (30.2%) 14 (18.2%) 2.0 [1.0, 3.8]

40% EWL 35 (21.6%) 4 (5.2%) 5.0 [1.7, 14.7]

50% EWL 24 (14.8%) 1 (1.3%) 13.2 [1.8, 99.6]

9.5.3 Improvements in Obesity Risk Factors

Table 9-8 illustrates the improvements seen in obesity risk factors for the VBLOC and

sham control groups. All obesity risk factors trended toward improvement with VBLOC

therapy and in the sham control group.

Improvements in patient questionnaires (i.e., IWQoL, Three Factor Eating Questionnaire)

were also observed consistent with the weight loss.

Table 9-8: Change in Obesity Risk Factors at 12 Months

Risk Factor

VBLOC Sham Control

Screening

Mean [95% CI]

Mean Change

from Screening

[95% CI]

Screening

Mean [95% CI]

Mean Change

from Screening

[95% CI]

Metabolic

Total Cholesterol (mg/dL) 204.2 [198.3, 210.2] -8.7 [-13.5, -3.8] 204.8 [196.5, 213.2] -9.7 [-16.9, -2.6]

LDL Cholesterol (mg/dL) 121.9 [116.8, 127.0] -5.2 [-9.6, -0.9] 122.5 [115.8, 129.2] -4.3 [-10.2, 1.7]

HDL Cholesterol (mg/dL) 54.3 [51.9, 56.6] 1.0 [-0.5, 2.5] 53.6 [49.3, 57.9] -0.4 [-3.0, 2.3]

Triglycerides (mg/dL) 141 [131, 151] -21 [-31, -12] 151 [127, 175] -33 [-48, 18]




Risk Factor

VBLOC Sham Control

Screening

Mean [95% CI]

Mean Change

from Screening

[95% CI]

Screening

Mean [95% CI]

Mean Change

from Screening

[95% CI]

Fasting Plasma Glucose

(mg/dL) 96.6 [93.7, 99.5] -1.5 [-4.1, 1.0] 98.4 [89.8,106.9] -0.7 [-3.5, 2.2]

HbA1c (%) 5.66 [5.56, 5.77] -0.33 [-0.40, -0.26] 5.85 [5.52, 6.18] -0.31 [-0.43, -0.20]

Cardiovascular

Systolic Blood Pressure

(mmHg) 127.4 [125.4, 129.4] -5.5 [-7.8, -3.2] 129.5 [126.3, 132.7] -4.0 [-7.3, -0.7]

Diastolic Blood Pressure

(mmHg) 80.7 [79.2, 82.2] -2.8 [-4.3, -1.2] 81.5 [79.1, 84.0] -4.5 [-6.5, -2.4]

Heart Rate (bpm) 76.2 [74.7, 77.8] -3.6 [-5.3, -1.9] 74.8 [72.3, 77.3] -3.5 [-6.3, -0.7]

Anthropometric

Waist Circumference

(cm) 121 [120, 123] -10 [-12, -8] 123 [120, 125] -8 [-10, -6]

9.6 Updated Results through 18 Months

Complete data were collected on 159 subjects (117 VBLOC and 42 sham control) at 18

months. Since the trial remained blinded until all subjects had completed the 12-month

visit, most subjects remained blinded for several months after the 12-month visit. The

median time to unblinding was 16 months for both groups. Specifically, at 15 months,

84% of VBLOC subjects and 90% of sham control subjects (86% total) remained

blinded. At 18 months, 27% of VBLOC subjects and 25% of sham control subjects (26%

total) remained blinded.

Efficacy through 18 months was assessed using three statistical techniques: a mixed-

effects regression model, the LOCF methodology, as well as without imputation. Results

from the mixed-effects model suggest that weight loss with VBLOC therapy was durable,

with an estimated mean 25.8% EWL at 12 months, 24.4% at 15 months, and 23.5% EWL

at 18 months. The sham control group regained a significant amount of weight following

the 12-month visit, with an estimated mean %EWL of 16.9% at 12 months, 12.9% at 15

months, and 10.1% at 18 months.

The treatment difference increased from 8.9 percentage points (95% CI: 4.3 to 13.5) at 12

months to 13.4 percentage points (95% CI: 8.4 to 18.4) at 18 months. This increase in

relative efficacy as a result of the sham control group gaining weight cannot be largely

attributed to unblinding since most subjects remained blinded until the 16-month visit.




Figure 9-2: Estimated Mean %EWL and 95% CI from Mixed-Effects Model through 18 months

The related SAE rate, the proportion of subjects in the VBLOC group who experienced

an implant/revision procedure, device, or therapy-related SAE, was 4.3% (95% CI: 1.8 to

8.7) in the ITT population at 18 months. One additional related SAE was a gastric

perforation that occurred in a female subject during explant of the device when she

decided to discontinue study participation. The safety SAE rate through 18 months

including those SAEs related to general surgical procedure was 9.3% (95% CI: 5.3 to

14.8) in the VBLOC group

Through 18 months there were no deaths or unanticipated adverse device effects

(UADEs) with the Maestro Rechargeable System. The overall adverse event profile at 18

months was similar to that observed through 12 months.




10. Individualization of Treatment

Best results are achieved when the patient is fully informed about the therapy risks and

benefits, surgical procedure, follow-up requirements, and self-care responsibilities.

Maximum benefits from the Maestro Rechargeable System require long-term

management.

10.1 Patient selection Select patients carefully to ensure that they are:

Appropriate candidates for surgery;

Can properly operate the system; and

Have no known allergies to implantable components of the Maestro Rechargeable

System.

10.2 Use in specific populations The safety and effectiveness of this therapy has not been established for:

Pregnancy, unborn fetus, or delivery;

Pediatric use (patients under the age of 18); or

Patients with a history of bariatric surgery, fundoplication, gastric resection or

major upper-abdominal surgery.

10.3 Patient counseling Patients should be counseled on healthy eating, being active and how to lose weight and

should be encouraged to participate in weight management sessions that are typically

conducted in bariatric clinical settings.




11. Operating Instructions

The Model 2200A and 2200P Leads are implanted onto the anterior and posterior vagal

trunks just above the esophago-gastric junction. The Model 2200P Lead is intended for

the posterior vagus, and is differentiated by a white suture wing and an embedded white

stripe that runs the length of the lead. The Model 2200A Lead is intended for the anterior

vagus, and has clear body tubing and a clear suture wing. Each lead is mechanically

retained within the neuroregulator by means of set screws that also assure electrical

contact. As shown in Figure 11-1, the posterior lead receptacle on the neuroregulator

header with a white septum, also identified with a P on the neuroregulator enclosure, is

for connection with the white posterior lead. The neuroregulator receptacle with a clear

septum, also identified with an A on the neuroregulator enclosure, is intended for

connection with the clear anterior lead. Each lead has silicone rubber insulation, flexible

conductors, and platinum iridium electrodes. Each lead has at least two types of suture

fixation, a suture tongue at the distal end of the lead, and a suture wing on the lead body.

The Model 2002 rechargeable neuroregulator may be placed subcutaneously in one of the

following locations:

a. Mid-axillary line of the thorax

b. Location determined by the surgeon and consistent with device operation.

The neuroregulator should be implanted between 2 and 3 cm below, and parallel to, the

surface of the skin.

Note: The neuroregulator must be placed not deeper than 4 cm below the

surface of the skin to ensure efficient charging and good communication between

the mobile charger and the neuroregulator.

The neuroregulator can be identified by an x-ray marker (EM2). Figure 11-2 shows the

Model 2200 leads and the Model 2002 neuroregulator.

Figure 11-1: Neuroregulator Header

Anterior lead

setscrew septum

Posterior lead

setscrew septum

Pressure relief

holes




Figure 11-2: Neuroregulator and Leads

The Model 2403-60 patient transmit coil (Figure 11-3), with a cable length of 60 cm, will

be provided to the patient for daily use with the Maestro Rechargeable System. The

Model 2403-300 clinician transmit coil is used during the surgical procedure and has a

cable length of 300 cm to allow the transmit coil to be used within the sterile field using a

sterile sleeve.

Nerve electrode

Suture tongue

Suture holes (3)

Suture wing

Setscrews

Anterior lead socket

Indicator

Posterior lead socket

indicator

Ring electrode




Figure 11-3: Model 2403-60 Transmit Coil

The Model 2402 mobile charger (Figure 11-4) is an electronic device used externally by

the patient during recharging of the neuroregulator. The major function of the mobile

charger is to provide the power necessary to recharge the battery inside the

neuroregulator and provide a communications path between the clinician programmer

and the neuroregulator. The mobile charger is also is powered by a non-replaceable

lithium ion rechargeable battery.

Figure 11-4: Mobile Charger

Display

Clinician programmer

port

Button Transmit coil

&

AC recharger port




Figure 11-5: Mobile Charger – Display Detail

The Model 2502 clinician programmer enables the clinician to configure and change

therapy parameters and the treatment schedule in the neuroregulator. It provides a

graphical user interface to help the clinician monitor the performance of the Maestro

Rechargeable System and patient compliance with device charging. In addition, the

clinician programmer provides access to the Maestro Rechargeable System manuals.

The clinician programmer is connected to the Model 2402 mobile charger with the Model

1600 programmer cable, as shown in Figure 11-6. This cable connects to a standard USB

port on the clinician programmer and the clinician programmer port on the mobile

charger.

Status Icon

Mobile Charger Battery Icon

Transmit Coil Position

Icon

Bar graph

Neuroregulator Battery Icon




Figure 11-6: Connecting the Mobile Charger & Clinician Programmer

11.1 Using the Mobile Charger

Preparing the Mobile Charger for Initial Use

The mobile charger is shipped in an inactive state. Press and release the button on the

mobile charger once to make it operational and wait a few seconds until the display icons

illuminate in sequence. Once operational, the mobile charger will shut off after several

minutes of inactivity to preserve battery longevity. The mobile charger will automatically

turn on when the button is pressed.

The mobile charger should be charged, using the AC recharger, for a minimum of 8 hours

prior to initial use. See the “Patient Operating Instructions” section of this manual for

instructions on charging the mobile charger.

Positioning the Transmit Coil over the Neuroregulator

Clinician programmer

port

USB connection on the

clinician programmer

connection

Transmit coil

&

AC recharger port




Finding the best position of the transmit coil over the neuroregulator is important to

ensure efficient charging and good communication between the mobile charger and the

neuroregulator.

Insert the transmit coil connector into the transmit coil port on the top side of the

mobile charger (Figure 11-4). The transmit coil position icon will be illuminated

as indicated in Figure 11-5.

With the transmit coil held away from the implanted neuroregulator, press and

hold the mobile charger button (Figure 11-4) for approximately two seconds until

the transmit coil position icon starts to flash and the bar graph is illuminated

(Figure 11-5).

Begin positioning the transmit coil by sweeping the transmit coil across the

neuroregulator in all directions, keeping the coil close to the body. The number of

illuminated bars on the bar graph indicator will increase and decrease.

Position the transmit coil to maximize the number of bars on the bar graph. One bar

indicates poor transmit coil position and five bars indicate the best transmit coil position.

Secure the transmit coil in the best position using the belt provided or another clinician

approved method. Press the button once to accept this position.

Once the transmit coil position has been accepted, the transmit coil position icon

will turn off.

Note: If the transmit coil becomes displaced, the mobile charger will

automatically illuminate the transmit coil position icon. The coil should be

repositioned as described above.

Note: Always hold on to the connector when connecting and disconnecting the

transmit coil. Do not pull on the cable to unplug the transmit coil connector from

the mobile charger.

Poor Signal

Strength

Strong Signal

Strength

Coil Position

Indicator




11.2 Maestro Rechargeable System Preparation Prior to Implantation

Neuroregulator Placement

It is important to assess placement of the neuroregulator prior to surgery. Assess the

placement with the patient in both the sitting and standing positions, to ensure patient

comfort, efficient charging and good communication between the mobile charger and the

neuroregulator. Discuss with the patient the device placement in the following order of

preference:

a. Mid-axillary line of the thorax.


Mobile Charger Preparation

The day prior to the implant procedure two mobile chargers should be fully charged

following the instructions in “Patient Operating Instructions” of this manual.

Entering Registration Information on the Clinician Programmer

On or before the day of surgery, registration information must be entered.

Note: During surgery, the lead status (impedance) test must be performed to

verify correct placement of the leads. This test cannot be performed until the

patient registration is complete.

Note: When the clinician programmer is used by a physician for the first time, it

is recommended that physician information is entered. For more information, see

the Clinician Programmer Manual.

To register a new patient:

1. Connect the clinician programmer to the patient’s mobile charger with the transmit

coil properly located over the neuroregulator.

Note: Registration may be performed with the neuroregulator in the sterile

package. Place the transmit coil over the sterile packed neuroregulator in a

position with at least four bars on the bar graph display of the mobile charger.

Note: For best communication between the clinician programmer and

neuroregulator, avoid any metal objects within three centimeters from the sterile

packed neuroregulator.

2. If the clinician programmer is communicating with the mobile charger and

neuroregulator, the “Registration” screen (Figure 11-7) will be displayed. This screen




may also be displayed by selecting the “Registration” icon.

3. Select the “Physicians” tab from the “Registration” screen (Figure 11-8). Check the

appropriate name on the physician list. If the physician’s name is not on the list, enter

the required information and press “Save Physician” to record the information.

4. Select the “Patient Registration” tab from the “Registration” screen (Figure 11-7) and

enter the required information. Press “Save Patient” to record the information.

Note: The clinician programmer will automatically enter the serial numbers of the

mobile charger and neuroregulator. The serial numbers of the leads must be

entered manually and must be re-entered any time the leads are replaced.

5. Check the battery charge level of the neuroregulator and recharge if necessary. For

more information see “Charging the Battery in the Neuroregulator” section of this

manual.

Note: The clinician programmer will record the date when patient registration

data is saved for the first time as the date of implant. If the registration

information is entered before the day of surgery, the implant date must be

manually updated.

Note: For detailed instructions on how to use the clinician programmer, consult

the Clinician Programmer Manual.




Figure 11-7: Registration Screen – Patient Registration




Figure 11-8: Registration Screen – Physician Information




12. Implant Procedure Summary

Note: Please see Maestro Rechargeable System Surgical Implant Procedure for

detailed instructions.

1. Prepare the patient for laparoscopic surgical placement of leads on the anterior and

posterior vagal nerve trunks.

2. Use standard laparoscopic technique to expose the intra-abdominal anterior and

posterior vagal trunks near the esophago-gastric junction.

3. During insertion through a trocar (minimum size 12 mm) the lead should be handled

without grasping or distorting the electrodes. Once inserted, grasp only the suture

tongue and/or the suture wing (Figure 11-2) of the lead. Avoid lead withdrawal

through the trocar.

4. Place the white-striped lead (2200P) on the posterior trunk. Use the suture tongue to

position the nerve electrode under the nerve. Anchor the lead by suturing the suture

tongue to the esophagus adjacent to the nerve.

5. Place the anterior lead with no stripe (2200A) on the anterior trunk. Use the suture

tongue to position the nerve electrode under the nerve. Anchor the lead by suturing

the suture tongue to the esophagus adjacent to the nerve.

6. Provide strain relief for each lead by suturing both sides of the suture wing close to

the esophago-gastric junction on the stomach. This allows for electrical contact of the

ring electrode to provide for diagnostic measurements of the system. Leave sufficient

lead length between the suture wing and suture tongue for each lead to prevent

tension on the nerve.

7. Verify that the nerves are properly seated within the electrodes.

8. Ensure that the suture through the suture hole of the suture tongue is firmly anchoring

the lead.

9. Externalize the leads by carefully withdrawing the lead connectors through a trocar

(minimum size 12 mm) adjacent to the site of lead connection. Extra lead length may

be gently pulled back into the abdominal cavity after connections to the

neuroregulator are made.

10. Create a pocket for the neuroregulator subcutaneously in the following order of

preference:

a. Mid-axillary line of the thorax.


The neuroregulator is positioned (with suture) at a depth between 2 and 3 cm below

the surface of the skin.




Note: The neuroregulator must be placed not deeper than 4 cm below the

surface of the skin to ensure efficient charging and good communication between

the mobile charger and the neuroregulator.

11. Ensure that the neuroregulator lead sockets are open by using the provided torque

wrench and back the setscrews out for three or more turns.

12. Insert the posterior lead (with white markings) into the posterior neuroregulator

socket (white septum). Verify that the lead is fully inserted by visually identifying

that the lead connector extends past each setscrew septum (Figure 12-1). Tighten the

setscrew to two clicks using the provided torque wrench.

13. Insert the unmarked anterior lead into the anterior neuroregulator socket (clear

septum). Verify that the lead is fully inserted by visually identifying that the lead

connector extends past each setscrew septum (Figure 12-1). Tighten the setscrew to

two clicks using the provided torque wrench.

14. Perform a lead status (impedance) test as described in the “Lead Status (Impedance)

Test in Surgery” section and ensure that the impedance values are in the allowable

range.

15. Use medical adhesive to seal the two pressure relief holes and the two septums in the

neuroregulator header. Figure 12-1 is a picture of the neuroregulator header prior to

medical adhesive application and Figure 12-2 is a picture of the neuroregulator after

medical adhesive is applied.

16. Use all three suture holes to secure the neuroregulator to the muscular fascia. This

prevents device migration and helps to maintain position approximately parallel to the

skin surface.

17. Perform another lead status (impedance) test as described in the “Lead Status

(Impedance) Test in Surgery” section.

18. The leads should be routed straight out from the neuroregulator and should exit the

pocket without forming any loops around the neuroregulator. Do not leave any

excess lead length in the pocket. This will facilitate safe operation of the system

during charging.

19. Close all incisions.

20. Perform the final lead status (impedance) test as described in the “Lead Status

(Impedance) Test in Surgery” section.

21. Activate the device and initiate therapy as described in the “Device Activation and

Treatment Initiation during Surgery” section.




Pressure Relief Holes

Setscrew Septums

Anterior Lead Tip

Pressure Relief Holes

Posterior Lead Tip

Figure 12-1: Lead Connection to the Neuroregulator Prior to Medical Adhesive Application

Figure 12-2: Lead Connection to the Neuroregulator after Medical Adhesive Application




13. Lead Status (Impedance) Test in Surgery

Note: The lead status (impedance) test should be conducted only when the

retractors are removed and after carbon dioxide insufflation.

Note: The lead status (impedance) test cannot be performed until the patient

registration is complete.

Note: During surgery, the lead status (impedance) test should be conducted with

the default amplitude of 3mA. After the final test is complete the lead impedance

amplitude must be reprogrammed to1 mA and saved. During the first follow-up

visit, the lead impedance test amplitude must be reprogrammed to 3 mA and

saved.

1. Place the clinician transmit coil in a sterile sleeve.

2. Connect the clinician transmit coil to the mobile charger.

3. Connect the mobile charger to the clinician programmer using the programmer cable.

4. Properly position the clinician transmit coil over the neuroregulator.

Note: With the neuroregulator outside the pocket, the best location for the

transmit coil may be found 1 or 2 cm above the neuroregulator.

5. Use the clinician programmer to perform the lead status (impedance) test. The

“Diagnostic” screen (Figure 13-1) displays the impedance values. A green check icon

will be shown for each lead configuration if the impedance measurement is in the

therapy delivery range (Table 13-1).

Note: The desirable range for the lead impedance values directly after the surgical

procedure is between 400 and 1000 Ohms.

6. If the lead status is not acceptable or the impedance is greater than 1000 Ohms, the

following should be considered:

a. Check the setscrew connections for each lead to the neuroregulator.

b. Clear all fluids from nerve electrodes.

c. Reposition, re-suture, or replace leads as appropriate.

Note: If the lead status (impedance) test could not be performed, reposition the

transmit coil as described above and repeat the test.

Note: Therapy will not be delivered at impedance levels below 400 Ohms and

above 1500 Ohms (Table 13-1).




Figure 13-1: Lead Status (Impedance) Test




Table 13-1: Lead Impedance Measurements

Low Impedance

(Short Circuit)

Acceptable Impedance Range High Impedance

(Open Circuit)

<400 Ohms 400 – 1500 Ohms >1500 Ohms

Therapy Delivery

Disabled Therapy Delivery Range

Therapy Delivery

Disabled

Electrodes may be

in contact with

each other or too

close together.

Impedances between 400 and 1000 Ohms are

desirable.

Impedances may change within the first

several days or weeks following lead

implantation.

Contact between

electrodes and the

nerve may be

insufficient or the

lead may be

damaged and

should be replaced.




14. Device Activation and Treatment Initiation during Surgery

14.1 Device Activation and Therapy Initiation

During surgery, the device will be activated and the initial treatment parameters set.

Note: Refer to the Clinician Programmer Manual for additional information

regarding clinician programmer functions.

The clinician programmer and the mobile charger are used to activate the device and

establish the therapy parameters and therapy delivery schedule:

1. Connect the mobile charger to the clinician programmer using the programmer cable.

2. Connect the transmit coil to the mobile charger and properly position the transmit

coil.

Note: If the clinician programmer message “Device Activation Needed”

appears, select “OK” and confirm when “Please Confirm Device Activation” is

displayed.

3. Ensure the clinician programmer is in communication with the mobile charger and the

neuroregulator by observing the dashboard on the “Summary” screen.

4. Select “Diagnostics” from the “Summary” screen to open the “Diagnostic” screen.

5. Perform a lead status (impedance) test.

6. Ensure that the Anterior to Posterior impedance is in the acceptable impedance range

(400-1500 Ohms). If the lead status test is not acceptable, contact EnteroMedics.

7. Select “Therapy” from “Summary” screen to open the “Therapy” screen.

Note: If the clinician programmer message “Device Activation Needed” appears,

select “OK” and confirm when “Please Confirm Device Activation” is displayed.

8. Ensure the therapy settings for parameter set 1 are “Enabled” and parameter sets 2

and 3 are “Disabled”.

9. The default therapy settings for parameter set 1 are the following:




Stop Real Time Test Start Real Time Test

Amplitude: 1.0 mA

Frequency 5000 Hz

Pulse Width 90 uS

Ramp Up 20.0 S

Ramp Down 0.0 S

ON Time: 5.0 Min: 2 ON/1 OFF

OFF Time: 5.0 Minutes

Lead Configuration: “Ant to Post”

10. Start the Real Time Test as shown in Figure 14-1. Stop the Real Time Test after a few

minutes when therapy delivery is shown on the Real Time Test screen.

Note: When the Therapy Timing is programmed to 5 minutes ON, the actual

therapy the Maestro Programmable System will deliver consists of 2 minutes ON,

1 minute OFF, 2 minutes ON, followed by the Therapy OFF time, as shown in

Figure 14-1)

Figure 14-1: Real Time Test

11. Adjust the therapy schedule if needed to deliver the prescribed hours of therapy

(Figure 14). Select “Save Changes” after the therapy schedule and parameters have

been established.

Note: It is recommended to adjust the therapy schedule to 13 hours of therapy

delivery during hours when the patient is awake.

12 Select the “Diagnostics” Screen to change the lead impedance test amplitude to 1

mA and save the changes (Figure 14-2).




Figure 14-2: Therapy Scheduler

Note: The patient should be instructed on the use of the mobile charger and how

to charge the mobile charger and neuroregulator before leaving the clinician’s

office. The patient should also be instructed to contact the clinician’s office if

there are any questions or unacceptable treatment related events.

14.2 Post Implant Healing Period In the post-operative period, some patients may experience a temporary drop in lead

impedance due to the healing process. This can result in impedance related events that

can suspend scheduled therapy delivery. During the first 11 days following therapy

activation, the Maestro Rechargeable System will suppress impedance related indications

and suspend scheduled therapy if any impedance related events occur. This feature is

intended to prevent undue patient concern and unnecessary clinic visits from impedance

related events due to the healing response.

Impedance related events will be cleared and scheduled therapy will be automatically

resumed once the 11 day period has elapsed.

If a clinic follow up visit occurs within the 11 days following therapy activation,

impedance related events will be cleared and normal operation will resume for the

duration of the clinician programmer session. When the session is closed, the system

operation for the 11 days following therapy activation as described above will resume.




15. Modifying Therapy Parameters during Follow-Up Visits

The therapy may be adjusted during subsequent follow up visits using the mobile charger

and clinician programmer:

1. Ensure the clinician programmer is connected to the mobile charger via the

programmer cable and the patient transmit coil is in proper alignment over the

neuroregulator.

Note: The connection between the neuroregulator, mobile charger, and clinician

programmer can be verified in the dashboard on the “Summary” screen of the

clinician programmer.

2. Select “Diagnostics” from the “Summary” screen to open the “Diagnostic” screen.

3. Perform a lead status (impedance) test. If the lead status test is not acceptable,

contact EnteroMedics.

4. Select “Therapy” from the “Summary” screen to open the “Therapy” screen.

5. The clinician may adjust the following settings as necessary:

a. Amplitude

b. Ramp Up Time

c. Therapy Schedule

6. Start the Real Time Test to confirm the patient can tolerate the therapy settings.

7. Select “Save Changes” after the therapy schedule and parameters have been

established.

15.1 First Follow-Up Visit

During the first follow up visit, the lead impedance test amplitude must be changed from

1 mA programmed at surgery, to 3mA, using the “Diagnostics” Screen.

Use the “Therapy” Screen (Figure 15-1) to increase the therapy amplitude to the

maximum the patient can reasonably tolerate up to 3mA. The ramp time may be adjusted

to improve patient tolerance of the therapy. Re-run the Real Time Test to confirm the

patient can tolerate the therapy settings. Save the changes.




Figure 15-1: Therapy Screen

15.2 Successive Follow-Up Visits

In order to maximize therapy, the proposed therapy setting will be at the maximum

therapy amplitude which the patient can reasonably tolerate with a therapy ON time of

five minutes. Therapy amplitude may be lowered based on patient tolerance. The ramp

time may be increased to improve patient tolerance of the therapy.

At each successive follow up, the capacity of the rechargeable battery in the

neuroregulator must be checked using the neuroregulator Battery Diagnostic Report

(Figure 15-3) and the Therapy Delivery Report (Figure 15-2). When the capacity of a

fully charged battery becomes insufficient for delivering the daily programmed hours of

therapy, the neuroregulator is approaching its end of life and replacement should be

considered. The neuroregulator Battery Diagnostic Report shows the frequency of




charging the neuroregulator battery and the Therapy Delivery Report shows the delivered

hours of therapy and occurrence of a low battery status. Neuroregulator replacement

should be considered when the neuroregulator battery is fully charged once per day,

however the programmed therapy hours for one day frequently cannot all be delivered

and a low neuroregulator battery status is reported daily as indicated in the Therapy

Delivery Report.

Figure 15-2: Therapy Delivery Report




Figure 15-3: Battery Diagnostic Report

15.3 Maestro Rechargeable System Reports

The clinician programmer may be used to display the following reports:

Therapy Delivery

Neuroregulator Battery Charge

Mobile Charger Battery Discharge

Lead Status

Therapy History

Refer to the Clinician Programmer Manual for additional information on these reports.




16. Maintaining the Maestro Rechargeable System

16.1 Maintaining the Neuroregulator If an activated neuroregulator is not recharged within a period of two months, the battery

within the neuroregulator may lose its capacity to be recharged and may no longer be

capable of delivering therapy.

If a patient and/or clinician make the decision to stop therapy, the neuroregulator battery

must be recharged fully. Use the clinician programmer to display the battery voltage. A

fully recharged battery will be greater than 3.85 V. The neuroregulator must then be

turned off. This can be accomplished by pressing and holding the button on the mobile

charger for more than 60 seconds until the display flashes the red status icon (Figure

11-5). A yearly visit to check the battery charge level and to recharge the neuroregulator

is required.

A deactivated neuroregulator may be reactivated by the clinician using the clinician

programmer. Please see the Clinician Programmer Manual for more details.

Note: When reactivating a neuroregulator, the clinician should check if the

mobile charger and the transmit coil of the patient are still operational. A new

mobile charger may be required if the patient has not recharged its battery during

the time of neuroregulator deactivation.

Note: The clinician should instruct patients about regularly recharging the

neuroregulator, about the risks of leaving an active neuroregulator uncharged for

more than two months and about the option to deactivate the device.

16.2 Maintaining the Mobile Charger and Transmit Coil

Clean the transmit coil and mobile charger when needed by using a damp soapy cloth.

Do not immerse the mobile charger or transmit coil in any liquid. Do not allow water to

enter into the connectors. Use a damp cloth to remove any soap residue. Allow

components to dry prior to use. One time per month, inspect the mobile charger and

transmit coil for wear or damage. Please contact Enteromedics should replacement

components be required.




17. Patient Operating Instructions

Charging the Battery of the Mobile Charger

To charge the mobile charger, connect the AC recharger to a power outlet. Then connect

the AC recharger to the AC recharger port on the mobile charger (Figure 4). The

indicator light on the AC recharger will be illuminated (orange or green).

Note: If the indicator light on the AC recharger is not illuminated, check if the

AC recharger is connected correctly to a wall outlet and the wall outlet is

switched on.

The mobile charger battery icon will be illuminated and the bar graph (Figure 11-5) will

flash sequentially from left to right, indicating that the battery is being charged.

Note: If the bar graph on the mobile charger does not illuminate, check if the AC

recharger is connected correctly to the mobile charger and press the button.

Note: If the mobile charger has not been charged for an extended period of time,

the mobile charger battery icon may not be illuminated. Leave the mobile charger

connected to the AC recharger for half an hour, then pressthe button on the

mobile charger again.

During charging, the indicator light on the AC recharger will be orange and will turn

green when charging is complete. The mobile charger battery icon and the bar graph will

continue to flash sequentially from left to right even when recharging is complete. It is

recommended to leave the mobile charger connected after it is fully recharged until it is

used. This will keep the battery fully charged and will not harm the mobile charger.

Note: Use only the AC recharger provided by EnteroMedics to recharge the

mobile charger.

17.1 Positioning the Transmit Coil over the Neuroregulator

Finding the best position of the transmit coil over the neuroregulator is important to

ensure efficient charging and good communication between the mobile charger and the

neuroregulator.

Insert the transmit coil connector into the transmit coil port on the top side of the mobile

charger (Figure 11-4). The transmit coil position icon will be illuminated as indicated in

Figure 11-5.

With the transmit coil held away from the implanted neuroregulator, press and hold the

mobile charger button (Figure 11-4) for approximately two seconds until the transmit coil




position icon starts to flash and the bar graph is illuminated (Figure 11-5).

Begin positioning the transmit coil by sweeping the transmit coil across the

neuroregulator in all directions, keeping the coil close to the body. The number of

illuminated bars on the bar graph indicator will increase and decrease.

Position the transmit coil to maximize the number of bars on the bar graph. One bar

indicates poor transmit coil position and five bars indicate the best transmit coil position.

Secure the transmit coil in the best position using the belt provided or another clinician

approved method. Press the button once to accept this position.

Once the transmit coil position has been accepted, the transmit coil position icon will turn

off.




Note: Always hold on to the connector when connecting and disconnecting the

transmit coil. Do not pull on the cable to unplug the transmit coil connector from

the mobile charger.

17.2 Checking Neuroregulator and Mobile Charger Battery Charge Levels

Position the transmit coil over the neuroregulator as described above. With the transmit

coil position icon off, press the button on the mobile charger once to display the battery

level of the neuroregulator. The neuroregulator battery icon will be displayed and the bar

graph will indicate the charge level of the neuroregulator (Figure 17-1).

While the bar graph is still illuminated, press the button for a second time. The mobile

charger battery icon will become illuminated and the bar graph will indicate the charge

level of the mobile charger (Figure 17-1).

Note: When the first segment of the bar graph is flashing, the battery must be

recharged immediately.

Note: The mobile charger battery should be fully charged before attempting to

recharge the neuroregulator.

Poor Signal

Strength

Strong Signal

Strength

Coil Position

Indicator




Figure 17-1: Battery Charge Level Examples

17.3 Charging the Battery in the Neuroregulator Position the transmit coil over the neuroregulator and check the battery charge level of

the neuroregulator as described above. If the bar graph shows five segments, the

neuroregulator is fully charged. No further charging is possible.

Note: The battery charge levels of the neuroregulator should be checked daily. It

is recommended to charge the neuroregulator when the bar graph shows four

segments. This will take approximately 30 minutes with proper coil placement.

Note: If the neuroregulator is charged when the bar graph shows less than four

segments, charging may take up to three hours.

Before recharging the neuroregulator, check if the mobile charger is fully charged and

recharge if necessary.

To start recharging the neuroregulator battery, press and hold the button while the

neuroregulator battery charge level is displayed. Release the button when the bar graph

begins to flash sequentially. The bar graph will continue to flash sequentially while the

neuroregulator is being charged.

The battery is fully recharged when the neuroregulator battery icon illuminates and the

Neuroregulator battery

needs recharging Mobile Charger battery

is fully charged




bar graph flashes five segments once every five seconds. The neuroregulator cannot be

overcharged.

Note: The mobile charger case may become warm during charging of the

neuroregulator. While charging, place the mobile charger in a position that allows

air circulation, do not lie in bed, sleep, sit or lie on the mobile charger, place the

mobile charger in clothing or place the mobile charger within a carrying case.




Note: If a neuroregulator is not charged within a period of two months, the

battery within the neuroregulator may lose its capacity to be charged and may no

longer be capable of delivering therapy.

Note: The patient must be instructed to fully charge the batteries of the

neuroregulator and mobile charger before visiting with their clinician.

17.4 Restoring the Mobile Charger’s Default Settings The mobile charger’s default settings may be restored by pressing and holding the

button for more than 15 seconds until the display icons illuminate in sequence.

17.5 System Alerts A status icon which is illuminated red, either continuously or intermittently, indicates that

the system is not delivering therapy (Figure 11-5). A red status icon does not indicate an

emergency condition. It just indicates that therapy is not delivered. The patient should be

instructed to contact their clinician during normal business hours to schedule an

appointment.




18. Deactivating the Neuroregulator

If required for deactivation or in an emergency situation, the neuroregulator may be

turned off. Position the transmit coil over the neuroregulator using instructions above,

press and hold the button on the mobile charger for approximately 60 seconds until the

display flashes the red status icon. If a mobile charger is not available, the neuroregulator

may be turned off by moving a medical device magnet over neuroregulator. Medical

device magnets are commonly found in emergency rooms.

A deactivated neuroregulator may be reactivated by the clinician using the clinician

programmer; please see the Clinician Programmer Manual for more details. Therapy is

not delivered when the neuroregulator is deactivated. Deactivation should only be

performed to preserve the rechargeable battery in the neuroregulator or in an emergency

situation.

Note: When reactivating a neuroregulator, the clinician should check if the

mobile charger and the transmit coil of the patient are still operational. A new

mobile charger may be required if the patient has not charged the battery during

the time of neuroregulator deactivation.

Note: The clinician should instruct patients about regularly charging the

neuroregulator, about the risks of leaving an active neuroregulator uncharged for

more than two months and about the option to deactivate the device.




19. Implant Removal and Disposal Instructions

19.1 Device Removal Training Surgeons are required to complete training and receive certification on completion of the

surgical explantation of the Maestro Rechargeable System prior to explanting a Maestro

Rechargeable System.

19.2 Removal of All Implantable Device Components Following are the general instructions for explant of the implantable device components.

Refer to EnteroMedics Surgeon Certification Training Program for detailed instructions.

1. Prepare patient for a standard laparoscopic surgical approach

2. Retract the liver

3. Identify lead bodies and follow down until the suture wings are identified on each

of the two leads.

4. Dissect along each lead towards the electrode.

5. Grasp electrodes and lift off of nerve. Rotate electrode away from nerve to expose

suture tongue.

6. Cut suture tongue to free electrode.

7. Free the suture wings.

8. Cut lead bodies as they enter abdominal cavity from the neuroregulator and remove

lead bodies from abdomen.

9. Surgically open the subcutaneous neuroregulator pocket.

10. Cut the sutures that secure the neuroregulator in position.

11. Remove the neuroregulator from pocket along with the remaining portion of the

leads that were inserted into the neuroregulator.

12. Verify that all system components have been removed.

13. Close all incisions.

Note: If removal of a lead poses a risk to the patient preventing its safe removal, the lead

may be left in situ, but only in its entirety as described below.

Surgeons are strongly recommended to remove the entire lead, including the

electrode, during an Implant Removal procedure. In the event removal of a lead

poses a patient risk, the lead should be left in place in its entirety, and covered

with a sterile silicone end cap designed for 3.2 mm diameter connector pins.

Specifically the Oscor VS-32 End Cap should be used to cap the lead according to

its instructions for use. A non-absorbable suture should be placed around the O-

ring on the cap to secure it to the lead. A suture should then be applied around the

silicone end cap and anchored in the subcutaneous pocket to secure the lead.

Please refer to the EnteroMedics Surgeon Certification Training Program for

detailed instructions.

Note: The lead should never be transected if it is to remain implanted. If a lead has been

transected it should be completely removed.




19.3 Replacement of Neuroregulator

Following are the general instructions for removal and replacement of the

neuroregulator. Refer to EnteroMedics Surgeon Certification Training Program

for detailed instructions.

1. Prepare patient for a standard laparascopic surgical approach. Note: The

abdomen may not need to be accessed for most neuroregulator

replacement procedures.

2. Surgically open the subcutaneous neuroregulator pocket. Care should be

taken when opening the subcutaneous pocket to proceed in a lateral to

medial direction. This is to avoid damaging the lead bodies.

3. Cut the sutures that secure the neuroregulator in position.

4. Remove the neuroregulator from pocket.

5. Undo the setscrews and remove leads from neuroregulator.

6. Replace the removed neuroregulator with a new neuroregulator.

7. Repeat steps #11-21 of the Implant Procedure Summary in Section 12 of

this document.

19.4 Device Disposal Place explanted device components in biohazard packaging and return all device

components to the corporate office of EnteroMedics, with a completed EnteroMedics

Returned Product Form (EnteroMedics document D00506-001, available from your

EnteroMedics representative) for proper analysis and disposal. Refer to EnteroMedics

Surgeon Certification Training Program materials for detailed instructions on biohazard

packaging and device return instructions. Under no circumstances should Maestro

Rechargeable System components be disposed of by incineration, including cremation.




20. Specifications

20.1 Component and Therapy Specifications

Model 2402 Mobile Charger

Internally powered 4.2 VDC maximum voltage, 1.3 Amps

maximum current

Liquid Ingress Rating IPX1

Continuous operation

Model 2403 Transmit Coil

Maximum Voltage 86 V p-p

Power 4.05 W rms

Frequency 6.78 MHz

Type Type BF applied part

Maximum Possible Temperature During

Charging 43 C

Model 1620 AC Recharger

Input Voltage 100-240 VAC

Input Current 0.2 A maximum

Input Frequency 50-60 Hz

Output Voltage 4.1 VDC maximum

Output Current 1.3 A

Model 2502 Clinician Programmer

Power Supply

Input Voltage 100-240 VAC

Input Current 1.6 A

Input Frequency 50-60 Hz

Output Voltage 19.5 VDC

Output Current 3.34 A




Model 2200 Lead Series

Connector (3.2mm) Compatible only with Maestro

Rechargeable System Neuroregulator

Pin Material Stainless steel

Insulation Silicone rubber

Lead Body

Insulation material Silicone rubber with white stripe

Overall lead length (nominal) 47 cm

Lead resistance (DC) 15 ohms nominal

Lead resistance (DC-Tip) 10 – 12 ohms

Lead resistance (DC-Ring) 8 – 10 ohms

Tip and Ring Electrode

Material Platinum Iridium

Suture Wing and Suture Tongue Silicone rubber

Suture Sleeve(s) Silicone rubber

Model 2002 Neuroregulator

Case Material Titanium

Header Material Tecothane

Setscrews Titanium

Connector Contacts MP35 and Stainless Steel

Seals Silicone Rubber and Medical Adhesive

Therapy Pulse Characteristics

Pulse Amplitude (maximum) 8.00 mA maximum

Pulse Width 90.00 µs

Pulse Rate 5.00 kHz

Useful Life of Rechargeable Battery –

Nominal and Worst Case Therapy

Settings

Testing supports that the longevity of the

battery will exceed 8 years




Maximum proven connector strength

between Model 2002 Neuroregulator and

Model 2200 Lead Series

10 N

Operational Environmental Parameters

for Model 2002 Neuroregulator

Temperature 16°C to 45°C

Humidity 10% to 90% RH non-condensing (before

implant) & 100% (after implant)

Pressure 70 to 150 kPa

Operational Environmental Parameters

for Model 2402 Mobile Charger &

Model 2403 Transmit Coil

Temperature 15°C to 40°C

Humidity 10% to 90% RH non-condensing


Shipping & Storage Parameters for all

Maestro Rechargeable System

Components

Temperature -10°C to 55°C

Humidity 10% to 90% RH non-condensing


20.2 Electromagnetic Compatibility Tables

Guidance and manufacturer’s declaration – electromagnetic emissions

The Maestro Rechargeable System is intended for use in the electromagnetic environment specified below.

The customer and or the user of the Maestro Rechargeable System should assure that it is used in such an

environment.

Emissions Test Compliance Electromagnetic environment – guidance

RF emissions

CISPR 11

Group 1

The Maestro Rechargeable System must emit

electromagnetic energy in order to perform

its intended function. Nearby electronic

equipment may be affected.




RF Emissions

CISPR 11

Class B The Maestro Rechargeable System is suitable

for use in all establishments, including

domestic establishments and those directly

connected to the public low-voltage power

supply network that supplies buildings used

for domestic purposes

Harmonic emissions

IEC 61000-3-2

Not Applicable

Voltage fluctuations/flicker

emissions

IEC 61000-3-3

Not Applicable

Guidance and manufacturer’s declaration – electromagnetic immunity



environment.

Immunity Test IEC 60601 test level Compliance level Electromagnetic environment –

guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

Complies Floors should be wood, concrete or

ceramic tile. If floors are covered

with synthetic material, the relative

humidity should be at least 30%

Electrical fast

transient/burst

IEC 61000-4-4

±2 kV for power

supply lines

±1 kV for input/output

lines

Not Applicable Mains power quality should be that

of a typical residential, commercial,

or hospital environment.

Surge

IEC 61000-4-5

±1 kV line(s) to line(s)

±2 kV line(s) to earth




Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

IEC 61000-4-11

<5% UT

(>95% dip in UT)

For 0.5 cycle

40% UT

(60% dip in UT)

For 5 cycles

70% UT

(30% dip in UT)

For 25 cycles

<5% UT

(>95% dip in UT)








For 5 sec

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m Complies Power frequency magnetic fields

should be at levels characteristic of a

typical location in a typical

residential, commercial, or hospital

environment.

NOTE UT is the a.c. mains voltage prior to application of the test level




environment.

Immunity Test IEC 60601 test level Compliance

level

Electromagnetic environment – guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

3V/m

80MHz to 2.5Ghz

3V

3V/m

Portable and mobile RF communications

equipment should be used no closer to any part

of the Maestro Rechargeable System, including

cables, that the recommended separation

distance calculated from the equation

applicable to the frequency of the transmitter.

d = 1.2 √P

d = 1.2√P 80MHz to 800MHz

d = 2.3√P 800MHz to 2.5GHz

where P is the maximum output power rating of

the transmitter in watts (W) according to the

transmitter manufacturer and d is the

recommended separation distance in meters

(m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,a

should be less than the compliance level in each

frequency range.b

Interference may occur in the vicinity of

equipment marked with the following symbol:





NOTE 1 At 80 MHz and 800MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from

structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,

amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the

electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Maestro Rechargeable System is used exceeds the applicable RF compliance level

above, the Maestro Rechargeable System should be observed to verify normal operation. If abnormal performance is observed,

additional measures may be necessary, such as reorienting or relocating the Maestro Rechargeable System.

b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.

Recommended separation distances between

Portable and mobile RF communications equipment and the Maestro Rechargeable

System

The Maestro Rechargeable System is intended for use in an electromagnetic environment in which radiated

RF disturbances are controlled. The customer of the user of the Maestro Rechargeable System can help

prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF

communications equipment (transmitters) and the Maestro Rechargeable System as recommended below,

according to the maximum power of the communications equipment.

Rated maximum output

power of transmitter

W

Separation distance according to frequency of transmitter

m

150kHz to 80MHz

d = 1.2 √P

80MHz to 800MHz

d = 1.2 √P

800MHz to 2.5 GHz

d = 2.3 √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

0 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be

estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from

structures, objects and people.




21. Maestro Rechargeable System Limited Warranty

This Limited Warranty is provided by EnteroMedics, 2800 Patton Rd, St Paul, MN 55113

USA. It applies only to commercially distributed product.

This LIMITED WARRANTY covers EnteroMedics Maestro Rechargeable System

components including the Rechargeable Neuroregulator (Model 2002), Anterior and

Posterior Leads (Models 2200A-47E, 2200P-47E), Mobile Charger (Model 2402), AC

Recharger (Model 1620), Patient Transmit Coil (Model 2403-60), Clinician Programmer

(Model 2502), Programmer Cable (Model 1600) and the Clinician Transmit Coil (Model

2403-300) (individually and collectively referred to as the "Product") such that should the

Product not function to specification within the period as specified in the table below,

EnteroMedics will repair the Product (which may include firmware updates) or provide a

replacement in accordance with the specified warranty terms for any Product that does

not function to specification, provided the lack of function is not due to causes listed

below. All Indications, Contraindications, Warnings and Precautions contained in the

Product labeling are an integral part of this LIMITED WARRANTY.

To qualify for this Limited Warranty, the following conditions must be met:

(1) EnteroMedics must be notified in writing within thirty (30) days after discovery of the

lack of performance to specification. EnteroMedics may repair or replace the defective

Product at its sole discretion. If the defective Product is replaced or removed, it must be

returned to EnteroMedics within thirty (30) days.

(2) The Product must not have been repaired or altered outside of EnteroMedics control

in any way which, in the judgment of EnteroMedics, affects its stability and reliability.

(3) The Product must not have been subjected to misuse, abuse or accident.

(4) The Rechargeable Neuroregulator must not have been improperly recharged, such as

an active neuroregulator which was not fully recharged at least once per two months or a

deactivated neuroregulator which was not fully recharged prior to deactivation.

(5) The Rechargeable Neuroregulator must not have been improperly implanted, such as

silicone adhesive applied with improperly inserted lead connectors, or damaged by

implantation tools.

(6) The Leads must not have been improperly implanted, for example, suturing around

the lead body or if the lead body, electrode or connector was damaged by laparoscopic

tools.

(7) The Mobile Charger, AC Recharger, Patient Transmit Coil, Clinician Transmit Coil,

Clinician Programmer or Programmer Cable must not have been improperly used. For

example, this Limited Warranty is void if the Product is submerged in fluids, physically

damaged or used with equipment not provided by EnteroMedics.




(8) Where applicable, the Product must have been put into use prior to its labeled “Use

Before” date.

This Limited Warranty is limited to its express terms. In particular:

(1) Except as expressly provided by this Limited Warranty, EnteroMedics is not

responsible for any direct, incidental or consequential damages based on any defect,

failure or malfunction of the Product.

(2) This Limited Warranty is made only to the purchaser of the Product. Other than this

Limited Warranty, EnteroMedics makes no other warranty, express or implied. This

limited warranty shall be the exclusive remedy available to any person.

(3) The exclusions and limitations set out above are not intended to, and should not be

construed to contravene mandatory provisions of applicable law. If any part or term of

this Limited Warranty is held to be illegal, unenforceable or in conflict with applicable

law by a court of competent jurisdiction, the validity of the remaining portions of this

Limited Warranty shall not be affected, and all rights and obligations shall be construed

and enforced as if this Limited Warranty did not contain the particular part or term held

to be invalid. This Limited Warranty gives the purchaser specific legal rights. The

purchaser may also have other rights which vary depending upon jurisdiction.

(4) No person has any authority to bind EnteroMedics to any representation, condition or

warranty except this Limited Warranty.

Maestro Rechargeable System Limited Warranty

Model Description Warranty Period Warranty

2002 Rechargeable

Neuroregulator

5 years from date of original

implant

100%

2200A-47E, 2200P-47E Anterior and

Posterior Leads

5 years from date of original

implant

100%

2402 Mobile Charger 1 year from date of original

implant

100%

1620 AC Recharger 1 year from date of original

implant

100%

2403-60 Patient Transmit

Coil

1 year from date of original

implant

100%

2403-300 Clinician

Transmit Coil

1 year from delivery date to

clinician

100%

2502 Clinician

Programmer


clinician

100%

1600 Programmer

Cable


clinician

100%




22. Contact Information

EnteroMedics Contact Information:

Corporate:

EnteroMedics Inc.

2800 Patton Road

St. Paul, MN 55113 USA

www.EnteroMedics.com

Phone: +1 651-634-3003

Fax: +1 651-634-3212

http://www.enteromedics.com/

Maestro® Rechargeable System

Patient Manual

CAUTION: Federal Law restricts this device to sale by or on the order of a physician.

Copyright 2015 by EnteroMedics Inc., St. Paul, Minnesota

All rights reserved

EnteroMedics, VBLOC and Maestro are registered trademarks of EnteroMedics Inc.

The Maestro System is protected under U.S., European, Japanese and Australian Patents, and patent

applications.

Subject to Pat. Nos.: AU2004209978; AU2009245845; AU2006280277; AU2006280278; AU2008226689;

AU2008259917; AU2011265519; US 7,167,750; US 7,672,727; US 7,822,486; US 7,917,226;

US 8,010,204; US 8,068,918; US 8,103,349; US 8,140,167; US 8,483,830; US 8,483,838; US 8,521,299;

US 8,532,787; US 8,538,542; US 8,825,164; JP 5486588; EP 1601414; EP 1603634; EP 1922109; and

EP1922111

For use in a method covered by Pat. Nos.: AU2009231601; US 7,489,969; US 7,729,771; US 7,613,515;

US 7,844,338; US 8,046,085; US 8,538,533

© EnteroMedics, Inc. 2015 Page 2 of 41

Table of Contents

1. GLOSSARY ....................................................................................................................................... 3

2. GETTING STARTED........................................................................................................................... 6

2.1 ABOUT THIS MANUAL .............................................................................................................................. 6

2.2 ABOUT OBESITY ..................................................................................................................................... 6

2.3 ABOUT THE MAESTRO SYSTEM AND VBLOC® THERAPY ................................................................................ 6

2.4 WHO IS A CANDIDATE FOR THE MAESTRO SYSTEM? ...................................................................................... 6

2.5 WHO IS NOT A CANDIDATE FOR THE MAESTRO SYSTEM? ................................................................................ 7

3. WARNINGS AND PRECAUTIONS ...................................................................................................... 8

3.1 WARNINGS ........................................................................................................................................... 8

3.1.1 Medical or Surgical Procedures ............................................................................................... 8

3.1.2 Radio Frequency Identification Devices (RFID) ........................................................................ 8

3.1.3 Magnetic Resonance (MR) Safety ............................................................................................ 8

3.1.4 Charging Your Neuroregulator Disc ......................................................................................... 8

3.1.5 Migration of Your Neuroregulator Disc ................................................................................... 9

3.2 PRECAUTIONS........................................................................................................................................ 9

3.2.1 Pregnancy ................................................................................................................................ 9

3.2.2 General .................................................................................................................................... 9

3.2.3 Temperature .......................................................................................................................... 10

3.2.4 EMI, RFID, Security and Theft Management Systems ............................................................ 11

3.2.5 Hyperbaric Chambers ............................................................................................................ 11

3.2.6 Telemetry Link ....................................................................................................................... 11

4. THE MAESTRO SYSTEM COMPONENTS ......................................................................................... 13

5. CHARGING THE MOBILE CHARGER AND THE NEUROREGULATOR ................................................. 15

5.1 CHARGING THE BATTERY IN THE MOBILE CHARGER ..................................................................................... 16

5.1.1 Troubleshooting: Charging the Battery in the Mobile Charger ............................................. 18

5.2 CHECKING THE BATTERY LEVEL OF YOUR MOBILE CHARGER .......................................................................... 19

5.2.1 Troubleshooting Tips: Checking the Battery Level of your Mobile Charger ........................... 19

5.3 POSITIONING THE TRANSMIT COIL ........................................................................................................... 20

5.3.1 Troubleshooting: Positioning the Transmit Coil ..................................................................... 21

5.4 CHECKING THE BATTERY LEVEL OF YOUR NEUROREGULATOR DISC ................................................................. 21

5.4.1 Troubleshooting Tips: Checking the Battery Level of your Neuroregulator Disc ................... 22

5.5 CHARGING THE BATTERY IN YOUR NEUROREGULATOR DISC .......................................................................... 22

5.5.1 Troubleshooting Tips: Charging the Battery in your Neuroregulator Disc ............................. 24

Maestro® Rechargeable System P01395-001 Rev G

Patient Manual

EnteroMedics, Inc.

6. LIVING WITH VBLOC THERAPY ...................................................................................................... 25

6.1 MAINTAINING THE CHARGE IN YOUR NEUROREGULATOR DISC ...................................................................... 25

6.2 MAINTAINING THE MOBILE CHARGER AND TRANSMIT COIL .......................................................................... 25

6.3 HOME AND WORK ENVIRONMENTS ......................................................................................................... 26

6.4 IF YOU BECOME PREGNANT ................................................................................................................... 26

6.5 THEFT DETECTORS AND SECURITY GATES .................................................................................................. 26

6.6 ELECTROMAGNETIC INTERFERENCE .......................................................................................................... 27

6.6.1 Hospital or Medical Environments ......................................................................................... 27

6.6.2 Home, Work or Public Environments ..................................................................................... 27

6.7 MAGNETIC RESONANCE IMAGING (MRI).................................................................................................. 27

6.8 TECHNICAL SERVICE INFORMATION .......................................................................................................... 28

7.1 THE IMPLANT PROCEDURE ..................................................................................................................... 29

7.2 RISKS AND BENEFITS ............................................................................................................................. 29

7.2.1 Risks of Abdominal Surgery and Treatment with the Maestro System ................................. 29

7.2.2 Benefits of the Maestro System ............................................................................................. 32

9. TURNING OFF YOUR NEUROREGULATOR DISC .............................................................................. 37

10. TROUBLESHOOTING ...................................................................................................................... 38

11. YOUR PATIENT IDENTIFICATION CARD .......................................................................................... 39

12. CONTACT INFORMATION .............................................................................................................. 40


Patient Manual

© EnteroMedics Inc 2014 Page 3 of 41

1. Glossary

Abbreviations and Acronyms

Term Description

AC Recharger Charges the battery of the mobile charger

AE Adverse Event

BMI Body Mass Index

EMI Electromagnetic Interference

%EWL Percent Excess Weight Loss

MRI Magnetic Resonance Imaging

MR Magnetic Resonance

MC Mobile Charger

PET Positron Emission Tomography

RF Radiofrequency

RFID Radio Frequency Identification

%TBL Percent Total Body Weight Loss

VBLOC Vagal Block for Obesity Control

Glossary

Term Description

Adverse Event Any troublesome medical episode in a patient

Atelectasis When your lung or a part of your lung becomes partially

impaired (it may partially collapse)

Cirrhosis A disease in which normal liver cells are damaged and are

then replaced by scar tissue

Diathermy

A procedure that heats and destroys tissue with short wave,

high-frequency electromagnetic radiation, electric currents,

or ultrasonic waves

Defibrillator A device used to shock a patient’s heart when it goes into a

life threatening rhythm

Electrocardiogram A record of the electrical activity of the heart showing

certain waves that are linked with contraction of the heart

Electromagnetic

Interference

Refers to a disruption from an electromagnetic energy

source that can affect the function of an electrical circuit


Patient Manual


Electrosurgical An electrosurgical tool that uses electricity

Esophagus The muscular food tube from the mouth to the stomach.

Esophageal Varices Veins at the lower end of the esophagus that are enlarged

and swollen can turn into ulcers and bleed

%EWL

Refers to weight loss as the percent of your extra weight

lost. For example if you are 100 pounds overweight and

you lose 30 pounds, your %EWL is 30%.

Gallbladder Disease

Inflammation of your gallbladder (a small organ next to

your liver) often caused by stones inside your gallbladder

that causes pain and discomfort and sometimes requires

medical or surgical treatment

Hiatal Hernia

Happens when part of your stomach pushes up on or

through the small opening in your diaphragm where your

food tube passes through on its way to connect to the

stomach

Hyperbaric

Chamber

Chamber designed to supply oxygen at a higher pressure

than normal air pressure

Ileus When the part of the small intestine does not move normally

Implant To place a device or object in a person’s body

Laparoscopic

A minimally-invasive surgical or diagnostic procedure that

uses a flexible endoscope (laparoscope) to view and operate

on structures in the abdomen

Lithotripsy The use of high-energy shock waves to break up kidney or

ureter stones

Magnetic Resonance

Imaging

A medical imaging technology that can get a highly refined

image of the body's interior without surgery by using strong

magnets and pulses of radio waves

Monopolar

Electrosurgical

Instruments

A type of surgical instrument that uses a single electrode to

deliver energy

Neuroregulator Refers to the Maestro System implantable disc that sends

very small electrical signals to the vagus nerve

Neurostimulator Is a device that is implanted in the body and designed to

provide an electrical stimulation to the nerves

Obesity Generally speaking, those individuals with a body mass

index (BMI) > 30 Kg/m2 are considered obese

Oncologic Radiation Radiation therapy using high energy to kill cancer cells

using Cobalt 60 or gamma radiation


Patient Manual


Portal Hypertension

High blood pressure in the liver veins. This condition can

happen with cirrhosis of the liver or other illnesses that can

cause a blockage in the liver veins

Radiofrequency

Ablation

The destruction of tissue during a surgery using an energy

source such as radiofrequency energy

RF Emitter A device that radiates radiofrequency signals

RFID

Radio Frequency Identification refers to a system with

which objects can be tracked and identified. It is used most

often in stores to prevent theft

Sleep Apnea It is a potentially dangerous sleep disorder during which

breathing repeatedly starts and stops.

%TBL

Refers to weight loss as the percent of your total body

weight lost. For example if you weigh 300 pounds

overweight and you lose 30 pounds, your %TBL is 10.

Telemetry Link Transmission of data or energy between two devices

without having direct contact

Vagus Nerve

The longest nerve in the body. The vagus nerve is one of the

nerves between the brain and the stomach that controls

hunger and feelings of fullness

VBLOC Therapy

Delivered by the Maestro System, VBLOC Therapy uses

high frequency to block messages in the vagus nerve

between the brain and the gut (stomach, liver, pancreas,

intestine)


Patient Manual


2. Getting Started

2.1 About this manual This manual is intended to reinforce the training you received from your doctor and nurse and

support your learning as you become accustomed to living with your Maestro System. If you

have any questions or concerns, contact your doctor or nurse right away or call 1800 MY-

VBLOC (1-800-698-2562) for technical support.

2.2 About Obesity

Two of every three adults in the U.S. are either overweight or obese. As a disease, obesity is one

of the leading causes of preventable death. Obesity can increase your risk of death from all

causes.

There are a number of weight loss options available, like diet and exercise, drugs and other

types of surgical procedures. After discussions between you and your treating doctors, you have

decided to take an important step in the management and control of your weight, using VBLOC

Therapy.

2.3 About The Maestro System and VBLOC® Therapy

The Maestro System is intended to help you lose weight by blocking signals in the nerves that

control how hungry you feel. This therapy is called VBLOC therapy.

The main component of the Maestro System is the neuroregulator disc. It is designed to operate

for up to 8 years. This disc is implanted just under the skin and is attached to nerves on your

stomach by two small leads (wires). These are implanted using minimally invasive surgery.

The Maestro System may help you feel less hungry. It may help you reduce the amount of food

you eat during a meal. You may feel full longer so that you don’t have to eat in between meals.

After you receive your Maestro System, it is important that you pay attention to the change in

your body’s hunger signals. You should stop eating when you feel full. You may be full after

eating smaller portions than you are used to eating.

The Maestro System will work best when used correctly, in combination with a healthy diet of

suitable portion sizes, and where possible, increasing the amount of physical activity you do

each day.

Your doctor or nurse will provide you with information on how to use the system. This manual

is intended to be used in addition to the information and instructions your doctor or nurse has

given to you.

2.4 Who is a candidate for the Maestro System? The Maestro System is intended for use by individuals aged 18 years through age 65 who are

obese, with a BMI of 40 to 45 kg/m2 or a BMI of 35 to 39.9 kg/m

2 with a related health

condition such as high blood pressure or high cholesterol levels. Individuals should have first

tried to lose weight by diet and exercise in a supervised program within the last 5 years before

receiving the Maestro System.


Patient Manual


2.5 Who is not a candidate for the Maestro System? You are not a candidate for the Maestro System if you have any of these medical conditions:

Cirrhosis of the liver

Portal hypertension

Esophageal varices

A hiatal hernia that is clinically significant and cannot be corrected by surgery

You are not a candidate for the Maestro System if you have another permanently implanted,

electrically powered medical device (such as a heart pacemaker, implanted defibrillator or

neurostimulator) or if your doctor does not feel it is safe for you to have surgery.

If you are not sure whether you have any of these conditions, consult with your doctor.

You should not have the following medical procedures if you have been implanted with the

Maestro System:

Magnetic Resonance Imaging (MRI) – The Maestro System is not safe for use with MRI

scans. Use of Magnetic Resonance (MR) could deliver energy to your implanted

device. This may cause tissue damage resulting in injury.

Diathermy – You CANNOT have surgical procedures where a shortwave, microwave, or

therapeutic ultrasound diathermy device may be used. The use of diathermy with the

Maestro System HAS NOT been studied but could deliver energy to your implanted

device. This may cause tissue damage resulting in injury.

Make sure that all of your health care providers know that you have the Maestro System

implanted, and show them your Patient Identification Card.


Patient Manual


3. Warnings and Precautions

3.1 Warnings

3.1.1 Medical or Surgical Procedures

DO seek guidance from your doctor before you undergo a medical or surgical

procedure. Some of these procedures may harm you, cause damage to your

neuroregulator disc or may turn therapy off. These may include:

Shock wave lithotripsy

Oncologic radiation or any cobalt 60 or gamma radiation

Mono-polar electrosurgical instruments

Positron Emission Tomography (PET) scans, or

Radiofrequency ablation

You CANNOT have surgical procedures where a diathermy device may be used.

The use of diathermy with the Maestro System HAS NOT been studied. Please

consult with your doctor before undergoing any procedure where diathermy may

be used.

Infections at the implant site have been observed, and severe infections could

require another surgery and removal of your device. You may need to be put on

antibiotic medications.

3.1.2 Radio Frequency Identification Devices (RFID)

RFID systems could produce electromagnetic interference with the Maestro

System. Please refer to section 3.2.4 “EMI, RFID, Security and Theft

Management Systems” for specific risks associated with RFID and other common

RF emitters.

3.1.3 Magnetic Resonance (MR) Safety

The Maestro System is MR unsafe and is contraindicated for anyone thinking of

undergoing a MRI procedure.

DO tell the radiologist, MRI nurse or technician if you were informed by your

surgeon that not all parts were removed after your Maestro System was explanted.

Tell them that you DO have remnants of a medical device that has been

categorized as MR unsafe.

3.1.4 Charging Your Neuroregulator Disc

DO fully charge your neuroregulator disc at least once every two months. If you

don’t regularly charge your neuroregulator disc, the battery may no longer be

chargeable. The neuroregulator disc may no longer be able to deliver therapy.

If you make the decision to stop therapy, fully charge the neuroregulator disc prior

to stopping therapy (deactivation). Your doctor MUST verify that the


Patient Manual


neuroregulator disc is fully charged before it is turned off. A deactivated

neuroregulator disc may be turned on by your doctor.

3.1.5 Migration of Your Neuroregulator Disc

DO NOT turn, twist or manipulate the neuroregulator disc in any way. This may

result in damage to the nerves or the implanted device. The leads of your Maestro

System can become entangled, fractured, or the insulation can erode. Therapy

delivery may be limited until a surgical repair or replacement can be performed.

Your neuroregulator disc will continuously monitor the leads and inform your

doctor during your follow-up about their condition.

3.2 Precautions

3.2.1 Pregnancy

Caution: The safety and effectiveness of the Maestro System has not been

established during pregnancy. As soon as you know you are pregnant, DO tell your

doctor so the neuroregulator disc can be fully charged and therapy can be stopped.

During your pregnancy, the leads of the Maestro System should be checked on a

regular basis by your doctor. The Maestro System has not been tested with fetal

monitoring systems and may interfere with their operation.

Inform your obstetrician about your implanted device before ultrasound or fetal

monitoring devices are used.

3.2.2 General

Caution: The safety and effectiveness of this device has not been determined for

patients under the age of 18 years.

Caution: The Maestro Rechargeable System may interact with implantable

devices such as cardiac pacemakers and defibrillators, implanted spinal cord and

peripheral nerve stimulators, other neurostimulators, and body worn medical

devices, such as insulin pumps.

Caution: The safety and effectiveness of defibrillation devices has not been

established with the Maestro Rechargeable System. If use of an external

defibrillator is necessary, it is possible that defibrillation energy may go through

the Maestro System leads (wires), possibly causing the defibrillation to not work

and damage the nerves.

Caution: Allergic reaction to the leads or the transmit coil of the Maestro System

is possible. Symptoms may include redness, swelling, itching, pain, etc. Discuss

with your doctor any symptoms related to a possible allergic reaction.

DO NOT operate the Maestro Rechargeable System in flammable environments.

Maestro Rechargeable System components produce small electrical currents that

may ignite flammable liquids and gasses.


Patient Manual


DO NOT use the mobile charger, AC recharger or transmit coil if they appear

damaged to avoid the potential for electric shock.

DO NOT attempt to modify or fix the equipment yourself. Contact your Doctor or

Technical Support at 1-800-MY-VBLOC (1-800-698-2562).

DO NOT pull, tie in knots, wrap around the mobile charger, or have stick pins

placed through the transmit coil cable. This could damage the device. The transmit

coil and cable should be regularly inspected for damage, to avoid a potential

electric shock.

DO NOT cover the mobile charger when in use. The mobile charger becomes

warm when charging. Overheating of the mobile charger could damage the device.

Keep the mobile charger well ventilated when in use.

DO NOT use the mobile charger when bathing, swimming, in a sauna or wet

environments. You should not expose the mobile charger or transmit coil to fluids.

This could damage the device.

ALWAYS turn the mobile charger off and disconnect the transmit coil when on

any aircraft so as not to potentially interfere with airplane operation.

If you have impaired vision, you may not be able to successfully operate the

Maestro System.

The capacity of the battery in the neuroregulator disc will be reduced over time.

You may have to charge more often as the neuroregulator disc nears the end of its

life.

DO NOT use any multiple outlet extension cords with the AC recharger. For

consistent operation of the AC recharger, connect the power cord directly to a

power outlet.

DO keep metal or strong magnets at least six inches away from the neuroregulator

disc. This includes metal or magnetic objects, such as those in speakers, Cathode

Ray Tubes (including television tubes), electric motors and on refrigerator and

freezer doors, power tools, as well as magnets used therapeutically or worn on the

body. Magnets may deactivate your neuroregulator disc. See section 3.2.4 “EMI,

RFID, Security and Theft Management Systems” for further possible effects of

exposure to strong magnetic fields or electromagnetic interference.

Do make sure that all of your health care providers are aware that the Maestro

System has been implanted. You should register your implant information with the

MedicAlert Foundation (www.medicalert.org) or equivalent organization.

3.2.3 Temperature

DO NOT use heating and cooling devices, such as electric blankets, heating pads,

hot and cold packs, near the implantation site. The neuroregulator disc is designed

to work between 16°C (60°F) and 45°C (113°F). If you are exposed to

temperatures outside of this range, the neuroregulator disc may stop working

(deactivate). You will see the red status icon on the mobile charger blinking any


Patient Manual


time you position the transmit coil. A deactivated neuroregulator disc may be

restarted by your doctor.

3.2.4 EMI, RFID, Security and Theft Management Systems

Caution: Radio Frequency Identification (RFID) systems may interfere with

your Maestro System and may result in longer charging times, or your

neuroregulator disc may be unable to fully charge. Your doctor should be aware

that RFID systems near the Maestro System in the clinic may result in difficulty

with programming the neuroregulator disc. RFID sources may be present in health

care facilities, retail stores, libraries, airports and other business environments.

DO tell people working with security and theft management systems that you have

a Maestro System, and show them your Patient Identification Card.

The effects of Electromagnetic Interference (e.g., electronic article surveillance

(EAS) systems, metal detectors, other security systems, strong magnetic fields etc.)

on device safety or performance are unknown. These systems may be strong

enough to interfere with the function of the Maestro System and may produce the

following effects:

‒ Serious injury: it is possible for these sources to generate enough energy in

the Maestro leads to damage the vagal nerve trunks and surrounding tissue.

‒ Damage to the Maestro System: resulting in permanent loss of therapy.

‒ Operational changes to the neuroregulator disc: resulting in therapy turning

off.

The Maestro System may activate EAS systems, metal detectors or other security

systems. DO NOT wear your mobile charger or transmit coil near these systems.

Strong magnetic fields and RF emitters, including RFID systems, may not always

be visible and could result in accidental exposure without your awareness. You

should keep as much distance between your Maestro System and these sources as

possible, and never recharge your neuroregulator disc when near these sources. We

recommend that you turn the neuroregulator disc off, using your MC, before you

enter an area with known strong magnetic fields.

If your device has stopped working because of exposure to a strong magnetic field,

then you must schedule a visit with your doctor to restart the neuroregulator disc.

Refer to section 10.0 “Electromagnetic Interference” for more information.

3.2.5 Hyperbaric Chambers

DO NOT use the Maestro System in a hyperbaric chamber. The effects on device

safety, operation or performance when within a hyperbaric chamber are unknown

and could result in damage to the device.

3.2.6 Telemetry Link

Caution: The telemetry link between the neuroregulator and mobile charger may

stop functioning when two or more Maestro Systems are operating within 10 cm of


Patient Manual


each other. The telemetry link will be re-established and normal operation will

resume when this distance is increased to greater than 10 cm.

Radio frequency transmitters operating near the neuroregulator and mobile charger

may affect battery charging; transmit coil positioning and device programming.

Issues may be resolved by moving to a different place.

Interference to the radio telemetry link between the neuroregulator and mobile

charger may be experienced in countries outside the USA, where frequency and

radio transmission may differ from those in the USA.

Interference to the radio telemetry link between the neuroregulator and the mobile

charger may be experienced when using EKG telemetry monitoring equipment

(e.g. portable telemetry units worn to record cardiac arrhythmias). These

monitoring systems may also be affected by the telemetry link of the Maestro

System.

Unintended access to the neuroregulator disc is prevented by the short range of

radio telemetry link and the way the neuroregulator disc and mobile charger

communicate.


Patient Manual


4. The Maestro System Components

Mobile Charger and AC Recharger

The mobile charger (MC) is used to charge the

neuroregulator. The MC has a button and a display which

shows information that is important to you, such as the battery

level. There are also two ports on the mobile charger, the

uncovered one is used to connect the mobile charger to both

the AC recharger and the transmit coil.

The second port, under the rubber cover, is only used by your

doctor or nurse. You should leave this port covered at all

times to protect it.

The battery in the mobile charger needs to be charged using

the AC recharger.

The Maestro Neuroregulator and Leads

The Maestro System is made up of multiple

components. A neuroregulator disc and leads

(wires) are implanted into your body during the

surgical procedure. In most cases, the

neuroregulator disc is implanted just under the

skin on the left side of your body, against your

ribs. You and your doctor can discuss the most

appropriate place for the neuroregulator to

allow for your comfort.

The Mobile Charger

AC Recharger

The Transmit Coil The Transmit Coil is used to help find the

neuroregulator disc and then works to charge the

neuroregulator disc when needed.

Neuroregulator and Leads

The Transmit Coil

The leads (wires) are implanted in your abdomen and are connected to the neuroregulator disc. The

neuroregulator disc creates very small electrical pulses that travel along the leads to the vagus nerve.

These pulses block nerve signals that control how hungry you feel. This can help you reduce the

amount of food you eat during a meal. You may feel full longer so that you don’t want to eat in

between meals. This is called VBLOC Therapy.

Mobile Charger

Transmit Coil


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The mobile charger status indicator tells you if your system is working. The indicator will be

green and blink from time to time when the system is working as intended.

The bar graph indicator at the bottom of the mobile charger display is used three ways, each

depicted by a unique symbol when that function is being used by the mobile charger:

The symbol shaped like a circle with a cross inside indicates the best position of the

transmit coil.

The symbol shaped like a battery indicates the battery level of your mobile charger.

The symbol shaped like a circle with a battery inside indicates the battery level of your

neuroregulator disc.

Only one of these symbols will light up at any given time. By looking at the symbol, you can

tell which function the bar graph indicator is showing.

The illustration below shows how the implantable and external components work together.

Lead wires

Neuroregulator

disc

Mobile

Charger

The Mobile Charger

Neuroregulator Disc Battery

Indicator

Mobile Charger Battery

Indicator

Transmit Coil Indicator

Transmit

Coil

Mobile Charger

Status Indicator

Bar Graph Indicator

Uncovered Port

Mobile Charger

Button

Covered Port


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5. Charging the Mobile Charger and the Neuroregulator

This section describes the charging process for your device. Please read the instructions

carefully before attempting to charge your system components.

Just like a mobile phone, your neuroregulator disc has a battery which must be charged daily. If

the battery is not charged, your neuroregulator disc will not be able to provide the therapy to

help you manage your weight. It is important that you keep the battery charged and check the

battery levels daily. When you travel, take your AC recharger, mobile charger and transmit coil

with you.

You cannot over-charge the battery in the neuroregulator disc. Charging the batteries cannot

harm you or damage the neuroregulator disc. Checking your battery levels every day and

charging them regularly will keep your neuroregulator disc functioning properly.

Please read the following instructions for detailed steps.

Section 5.1 Charging the battery in the mobile charger

Section 5.2 Checking the battery level of your mobile charger

Section 5.3 Positioning the transmit coil

Section 5.4 Checking the battery level of your neuroregulator disc

Section 5.5 Charging the battery in your neuroregulator disc


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5.1 Charging the Battery in the Mobile Charger

1. Connect the AC recharger to a powered wall outlet. Use only the power cord provided to

you by your doctor.

2. Attach the connector on the short wire of the AC recharger to the port on the mobile

charger.

Power Cord

AC Recharger

Mobile Charger

AC Recharger

Short Wire of the

AC Recharger

MC Button


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3. Check that the indicator light on the AC recharger turns orange. This indicates that the MC

is charging.

4. The MC will show a single lighted segment on the bottom of the bar graph moving from left

to right. If the bar graph remains blank, the MC is not charging and you should refer to the

trouble shooting guide at the end of this section.

Note: Allow the mobile charger to charge for an extended period of time. An MC with a low

battery charge may take several hours to reach a full charge. Also, keep the MC and AC

recharger in a cool and well ventilated location while charging.

Indicator Light on AC

Recharger will be orange

Single lighted Segment moving left to right

Mobile Charger

Charging Display


Patient Manual


5. Once the MC is fully charged, the light on the AC recharger will turn green. The display on

the MC’s bar graph will continue to show a single lighted segment moving from left to right

as shown in the MC charging sequence in point 4.

You can leave the AC recharger connected to the Mobile Charger until you are ready to charge

your neuroregulator disc. This will ensure the MC will always be fully charged and ready for

use. Remember – you cannot overcharge the MC.

Always take care when connecting or disconnecting the AC recharger to the MC and do not pull

on the cable.

5.1.1 Troubleshooting: Charging the Battery in the Mobile Charger

If the bar graph on the MC display remains blank, it is not charging. To resolve this:

With the MC connected to the AC recharger, press and release the MC button

once. This sends a wake-up signal to the MC.

If the MC charging display does not begin within 30 seconds, wait half an hour

and press the button again.

If the light on the AC Recharger remains green when the MC is

connected to the AC Recharger, the MC is not charging. To resolve

this:

Leave the power cord of the AC Recharger connected to the wall outlet and leave

the MC still connected to the AC recharger.

Then disconnect and quickly reconnect the power cord from the AC recharger.

Check the indicator light in the AC recharger. Orange indicates the MC is

charging. Repeat this process if the indicator light is still green.

Note: If the AC Recharger indicator remains green after several tries, the MC may be

full and not require recharging.

Indicator Light on AC

Recharger will be Green


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5.2 Checking the Battery Level of your Mobile Charger

1. With the MC disconnected from the AC Recharger and the transmit coil, press the MC

button once.

2. The mobile charger battery indicator will light up and the bar graph will indicate the charge

level of the mobile charger’s battery.

Note: If the bar graph indicator shows all five bars, the battery in the mobile charger is full. The

mobile charger is ready to charge the battery in your neuroregulator disc.

If the bar graph indicator shows four bars or less, the battery in the mobile charger needs to be

charged. Proceed with the instructions in Section 5.1 “Charging the Battery in the Mobile

Charger.”

5.2.1 Troubleshooting Tips: Checking the Battery Level of your Mobile Charger

If the MC battery indicator is on and the first bar on the bar graph is flashing, the mobile

charger battery is low and must be charged before use. To resolve this:

Follow the instructions in Section 5.1 “Charging the Battery in the Mobile

Charger.”

MC is Fully Charged


Patient Manual


5.3 Positioning the Transmit Coil

1. Disconnect the AC recharger from the mobile charger.

2. Attach the transmit coil (TC) to the uncovered port on the fully charged mobile charger.

3. Holding the transmit coil away from your body, press and hold the MC button until the

transmit coil indicator starts to flash.

4. Bring the coil up to your body and slowly sweep it COMPLETELY across the location of

your neuroregulator disc. Look at the bar graph on the bottom of the MC display. The

display should change as you move the coil.

Transmit Coil Indicator Flashing

Transmit Coil

Connected


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5. Move the transmit coil back to the position that shows the most bars on the bar graph.

Note: Typically, 4 or 5 bars result in the quickest charging of your neuroregulator disc.

You may secure the transmit coil in the best position with an elastic belt or any other method

that is comfortable for you and does not contain metal or magnetic objects within at least six

inches of the transmit coil.

5.3.1 Troubleshooting: Positioning the Transmit Coil

If during charging of your neuroregulator disc the transmit coil becomes displaced, the

transmit coil indicator will light up. To resolve this:

Try moving the coil back into position to see if charging resumes.

If the coil indicator does not go off, reposition the transmit coil as described in

section above (Section 5.2).

If the red status indicator starts blinking, your neuroregulator disc cannot be charged.

Contact your doctor or nurse during normal business hours. This does not

indicate an emergency. It means you need some support from your doctor or

nurse to trouble-shoot the system.

5.4 Checking the Battery Level of your Neuroregulator Disc 1. Position the transmit coil over your neuroregulator disc as described in Section 5.3

“Positioning the Transmit Coil.”

2. As soon as the display of the mobile charger goes blank, press the MC button on the mobile

charger once.

3. The neuroregulator disc battery indicator will light up and the bar graph will indicate the

charge level of the battery in your neuroregulator disc.

Locating the

Neuroregulator Disc


Patient Manual


Note: The bar graph indicator should show 5 bars meaning the neuroregulator disc is fully

charged. If the bar graph indicator shows four bars or less, the battery in the neuroregulator disc

needs to be charged. Proceed with the instructions in Section 5.5 “Charging the Battery in your

Neuroregulator Disc.”

5.4.1 Troubleshooting Tips: Checking the Battery Level of your Neuroregulator Disc

If the first bar on the bar graph is flashing, the battery level of the neuroregulator disc is

very low and must be charged as soon as possible. To resolve this:

Follow the instructions in Section 5.5 “Charging the battery in your

Neuroregulator Disc.”

If you press the MC button two or three times you will pass the menu item that helps

you check the battery level of the neuroregulator disc. To resolve this:

Press the MC button a fourth time and wait for the display to return the mobile

charger menu to its original blank position, and repeat Section 5.4 “Checking the

Battery Level of your Neuroregulator Disc.”

5.5 Charging the Battery in your Neuroregulator Disc

1. Check to make sure your mobile charger is fully charged as described in Section 5.2

“Checking the Battery Level of your Mobile Charger.”

Fully Charged Needs to Be Charged


Patient Manual


2. Check the battery level of your neuroregulator disc as described in 5.4 “Checking the

Battery Level of your Neuroregulator Disc.”

Note: If the bar graph indicator shows all five bars, the battery in your neuroregulator disc is

fully charged, you will not be able to charge your device.

3. With the battery level of the neuroregulator disc still displayed by the bar graph, press and

hold the MC button. As soon as you see the lighted segment of the bar graph on the display

moving from left to right, release the MC button.

Fully Charged

Mobile Charger

Neuroregulator Disc

Needs to Be Charged

Neuroregulator disc is being charged


Patient Manual


4. Allow the neuroregulator disc to charge until it becomes fully charged (all 5 bars flashing at

the same time) or until the MC battery becomes fully depleted (MC display has gone

blank).

Note: During charging of your neuroregulator disc, the battery in the mobile charger will

deplete.

Note: Continue to charge the neuroregulator disc without stopping even if the mobile charger

shows its battery is low (MC battery icon flashes).

5. Once you have completed charging your neuroregulator disc, disconnect the transmit coil

and proceed with the instructions in Section 5.1 “Charging the Battery in the Mobile

Charger.”

Note: The charging time will typically take 30 to 60 minutes when you charge your

neuroregulator disc with the battery level at four bars on the bar graph indicator. Uninterrupted

charging with a transmit coil in the best position will result in the shortest charging time.

Note: While charging the neuroregulator disc, keep the mobile charger in a cool and well

ventilated location. The mobile charger may heat up during use; this is a part of normal use.

5.5.1 Troubleshooting Tips: Charging the Battery in your Neuroregulator Disc

If the Transmit Coil moves out of position during charging, the green transmit coil icon

will light up and charging will stop. To resolve this:

Move the coil back to the position you selected in Section 5.3 “Positioning the

Transmit Coil.” When the coil is positioned correctly, the green transmit icon

will go away on the MC display.

If the charging sequence on the MC display is blank, the mobile charger may not be

fully charged. To resolve this:

Check the charge on the MC. You should fully charge the MC battery before

returning to charge the neuroregulator disc.

If you have not charged your neuroregulator disc in a few days, your MC battery may

deplete before your neuroregulator disc battery is fully charged. To resolve this:

Recharge the MC as above and charge your neuroregulator disc again.


Patient Manual


6. Living with VBLOC Therapy

In addition to the information included in this guide, your doctor and nurses will give you

detailed instructions about living with VBLOC Therapy.

To get started, here are a few important steps you’ll need to take when living with VBLOC

Therapy:

You can keep the mobile charger attached to a power source when not in use. This will

ensure that the mobile charger will always be charged and ready for use.

Keep the mobile charger and the transmit coil clean and dry.

Visit your doctor regularly.

Although you aren’t required to restrict the types of foods in your diet, it’s important to

take an active role in your health. Follow your doctor and nurses’ diet and eating

guidance and take your prescribed medications.

In the main clinical study of the Maestro System (called the ReCharge Study) patients

who received VBLOC therapy also received counseling on healthy eating, being active

and how to lose weight. Studies have shown that treatment for weight loss (such as diet

drugs or weight loss surgeries) is more effective when combined with diet and exercise.

6.1 Maintaining the Charge in your Neuroregulator Disc You should get into the habit of charging your neuroregulator disc using the mobile charger

daily. You should also leave the AC recharger connected to the mobile charger and power outlet

during the time you do not need your mobile charger.

If you don’t charge your neuroregulator disc for two months or longer, the neuroregulator disc

may no longer be able to deliver therapy.

If you and your doctor decide to stop the therapy, the battery in the neuroregulator disc must be

fully charged before the neuroregulator disc is turned off. If you do this, you should make a

yearly visit to your doctor to check the battery charge level of your neuroregulator disc.

6.2 Maintaining the Mobile Charger and Transmit Coil Your mobile charger and transmit coil are electrical devices, they are not intended to be used

when showering, bathing, swimming, or in a sauna.

You may clean the transmit coil and mobile charger from time to time with a damp soapy cloth.

Do not place or splash the mobile charger or transmit coil in any liquid. Use a clean damp cloth

to remove any soap residue. Allow components to dry before you use them.

If you use an elastic belt to hold the transmit coil in place, you may wash the belt by hand or

with a machine using a cold, gentle cycle and air dry.

Check the mobile charger, transmit coil, and AC recharger regularly for wear or damage.

Discuss the condition of these components with your doctor or nurse during follow up visits so

they make certain your Maestro System is working properly at all times.


Patient Manual


6.3 Home and Work Environments Your neuroregulator disc can be turned off in an emergency situation by placing a strong

magnet over it. If you have magnets, you must be careful to keep a six inch distance between

the magnets and your neuroregulator disc. Many refrigerators and freezers have a magnetic strip

in the door. Be careful not to lean against this magnetic strip.

Keep metal and magnetic objects at least six inches away from the transmit coil during

recharging of the neuroregulator disc.

Equipment that generates large magnetic fields may turn off your neuroregulator disc if you are

in close proximity. They can include:

Electric arc or resistance welding equipment

Electric induction heaters

Electric “blast” furnaces found in steel mills

Your neuroregulator disc is turned off when the red status indicator on the MC starts blinking

after you position the transmit coil. This does not indicate an emergency. It indicates you must

contact your doctor during normal business hours to schedule an appointment.

6.4 If You Become Pregnant The safety and effectiveness of the Maestro System has not been established for use during

pregnancy. As soon as you know you are pregnant, you must contact your doctor or nurse. They

will instruct you to fully recharge your neuroregulator disc and visit the office to turn off your


Because leads (wires) are implanted in your abdomen, your doctor will monitor the position of

these leads relative to the fetus on a regular basis.

The Maestro System has not been tested with fetal monitoring systems and may interfere with

their operation.

6.5 Theft Detectors and Security Gates

Recharging the neuroregulator disc close to a theft detector or security gate should be avoided.

The neuroregulator disc may set off theft detectors.

Walk through security arches or gates found in department stores, libraries, government

buildings, airports, etc. at your normal pace. Do not stand near them for long periods of time.

When at the airport and security personnel are available, avoid walking through security gates.

Instead show the Patient Identification Card and ask for a pat down. Some airports use security

wands. Ask security personnel to avoid passing the wand directly over your neuroregulator disc

since this may stop therapy. For more information, contact your local airport security office or

TSA (Transport Safety Administration).


Patient Manual


6.6 Electromagnetic Interference Electromagnetic interference (EMI) is a field of energy generated by equipment found in the

home, work, medical, or public environments. Strong electromagnetic forces and permanent

magnets can stop your device from working (see section 3.2.4 “EMI, RFID, Security and Theft

Management Systems”).

6.6.1 Hospital or Medical Environments

You should always inform medical staff that you have an implanted Maestro System (and show

your Patient Identification Card) before any procedure is performed. Most diagnostic

procedures, such as x-rays and ultrasounds, may be performed safely. Other stronger diagnostic

and therapeutic equipment may interfere with the Maestro System. Refer to Section 3

“Warnings and Precautions.”

6.6.2 Home, Work or Public Environments

You should AVOID or use caution when in the presence of the following:

‒ Radiofrequency identification (RFID) sources

‒ Power lines and transmission towers

‒ Electric Substations, power generators and large transformers

‒ Portable and mobile RF communications equipment

‒ Electric arc welding equipment

‒ Electric steel furnaces

‒ Electric induction heaters

‒ Electric fences

‒ Jackhammers

‒ Stun guns

For more information about devices that generate EMI contact your doctor or EnteroMedics at

1-800-MY-VBLOC (1-800-698-2562). If you suspect EMI is impacting the performance of

your Maestro System, move away from the source of the EMI.

6.7 Magnetic Resonance Imaging (MRI) An MRI is performed using powerful magnets and radio frequency energy. The Maestro System

is not compatible with MRI equipment. The procedure may result in nerve damage, burns,

heating or pain. Before you undergo an MRI procedure, you must contact your nurse or doctor

and inform them of the planned procedure. If the procedure is necessary, tell the radiologist,

MRI nurse or technician that you have a medical device that is MR unsafe.


Patient Manual


You should register your Maestro System with the MedicAlert Foundation

(www.medicalert.org) or an equivalent organization. This will ensure doctors and nurses get up-

to-date medical information on your medical device.

6.8 Technical Service Information The Maestro System should not be repaired by untrained people. Do not open any system part

since it may cause damage to the device.

If parts of the device are damaged, contact your doctor or nurse during regular business hours to

schedule an office visit or call 1800 MY-VBLOC (1-800-698-2562) for technical support.


Patient Manual


7. What to Expect with the Maestro System

7.1 The Implant Procedure You will need to have the Maestro System implanted at a hospital. The implant procedure can

be done as a “same day” surgery. Please speak with your doctor and nurse to determine how

long you might stay in the hospital.

Prior to the implant you may have some tests that could include:

Measure your pulse, body temperature, and blood pressure

Review of your current medicines

Your weight

Other tests such as blood work or an electrocardiogram

You will not be awake during the surgery. Your doctor will implant the Maestro System

laparoscopically.

Laparoscopic surgery is done by using up to 5 small incisions in the abdomen and then

operating through small tubes placed through these incisions. During this surgery, your doctor

will place one lead (wire) next to each of the two main parts of the nerve just above your

stomach.

Your doctor will then place a neuroregulator disc under your skin. The best location for this disc

will be determined by you and your surgeon prior to surgery. Your doctor will test the device

and start the therapy during the surgery. Your doctor will make sure the device is working

before you leave the operating room.

Your doctor or nurse will teach you how to use the Maestro System.

7.2 Risks and Benefits There are risks and benefits with all medical procedures. Talk to your doctor about the risks

and benefits of the Maestro System to see if it is right for you. Your doctor can answer

questions about the information in this manual.

7.2.1 Risks of Abdominal Surgery and Treatment with the Maestro System

There may be risks when using the Maestro System. They may include complications from the

surgery, and also risks due to the use of the Maestro System.

The following risks may occur as a result of your surgery and the implantation of the Maestro

System. They may also occur if you need to have the device removed after placement. Discuss

these risks with your doctor.


Patient Manual


Possible Risks of Surgery

Event Likelihood of Event

Happening to Patient*

Effect

Pain at the disc site 19 of 100 procedures Pain where the disc is placed

Wound redness or irritation 5 of 100 procedures Incision site becomes red or irritated

Nausea 4 of 100 procedures Upset stomach with or without

vomiting (throwing up)

Swallowing difficulty 3 of 100 procedures Food getting stuck, temporarily hard to

swallow

Dehiscence (opening of

incision site)

2 of 100 procedures Incision site opens and needs to be re-

sutured

Incision pain 75 of 1000 procedures Discomfort at the site of the incisions

Left shoulder or throat pain 54 of 1000 procedures Discomfort in the upper arm or throat

Constipation 25 of 1000 procedures Unable to have a normal bowel

movement

Abdominal pain 25 of 1000 procedures Pain or discomfort in the stomach or

abdominal organs

Vomiting 13 of 1000 procedures Vomiting (throwing up) may

sometimes be severe and on rare

occasion can cause the stomach to go

up into the chest

Infection next to implanted

disc or leads

13 of 1000 procedures Location where implanted disc is

placed becomes infected with pus and

drainage

Infection of trocar site 13 of 1000 procedures Location where trocar is placed

becomes infected with pus and

drainage

Bleeding at surgical site 8 of 1000 procedures Bleeding from the sites where the

surgery was performed

Breathing complications 8 of 1000 procedures Hard time breathing

Abdominal bloating or

difficulty passing gas

8 of 1000 procedures Stomach feels full of gas

Ileus 4 of 1000 procedures The small bowel (intestine)

temporarily slows down or stops

Injury to internal organs 12 of 10,000 procedures^ Injury to the stomach, liver, intestine

or other internal organs due to surgery

*From the ReCharge Study through the first year after implantation unless noted

^From the ReCharge study through the first year and one half after implantation


Patient Manual


Rarely, a small hole could be made in the esophagus or stomach which would need to be

repaired. It would be expected that any problems due to a hole occurring would be temporary.

There have been no deaths caused by the Maestro System in the ReCharge Study. Death is a

rare possibility with laparoscopic surgery. It has been reported in 2 out of 1000 patients after

laparoscopic surgery for a gastric band for weight loss (Ren CJ, et al. Surgical Endoscopy

2004; 18: 543-546). Pulmonary embolism (blood clot in the lungs) also did not occur in the

ReCharge Study. It has been reported after laparoscopic surgery at a rate of 9 out of 1000

patients (Gargiulo NJ, et al; Annals of Vascular Surgery. 2007 21:556-9).

As described above, risks may happen after surgery, from using the device or from weight loss.

Those risks are described below.

Risks that may occur following your surgery, as a result of weight loss or from using the device

Event Likelihood of Event

Happening to Patient*

Effect

Abdominal pain 21 of 100 procedures Pain or discomfort in the

stomach or abdominal organs

Belching 5 in 100 procedures Burping

Device stops working 2 of 100 patients who had the

Maestro System implanted

Disc stops working and need

another surgery to place a

new disc.

Pain at the disc site 238 of 1000 procedures Pain and discomfort when

lying on top of disc or when

the disc is bumped. In some

cases pain at the disc site or

movement of disc from the

original position may require

that the disc be moved to

another location under the

skin or be re-sutured in the

original position which

requires another surgery.

Heartburn 163 of 1000 procedures Pain or discomfort in the

throat

Chest pain 42 of 1000 procedures Pain or discomfort in the

chest

Swallowing difficulty 33 of 1000 procedures Difficulty in passing food

through the esophagus and

into the stomach.

Constipation 29 in 1000 procedures Cannot have a normal bowel

movement

Appetite increases 29 in 1000 procedures Feel more hungry


Patient Manual


Headache 21 in 1000 procedures Head hurts

Bloating 17 in 1000 procedures Stomach feels full of gas

Vomiting 17 in 1000 procedures Threw up food or drink

Diarrhea 13 in 1000 procedures Runny stools

Nausea 13 in 1000 procedures Feel like throwing up

Dizzy/lightheadedness 13 in 1000 procedures Loss of balance, or feeling

faint

Vitamin or mineral deficiency 8 in 1000 procedures Blood tests show that vitamin

or mineral levels are low

Erosion or wire breakage 4 of 1000 procedures through

18 months

The wire breaks requiring

another surgery to place a

new wire.

Potential allergic reaction with

implanted or skin contact

materials

4 of 1000 procedures Redness formed on the skin

where the coil was placed,

and/or swelling

Therapy delivery stopped when

passing through theft detector

gates

4 of 1000 patients who had the

Maestro System implanted

Therapy is not delivered for a

short period of time but starts

up right away

Seroma 4 in 1000 procedures Swelling under skin due to

tissue fluid pooling where

surgery was performed

Flatulence 4 in 1000 procedures Passing gas

Depression 4 in 1000 procedures Feel sadder than usual

If diabetic, may experience

hypoglycemia

4 in 1000 procedures Low blood sugar

Formation of gallstones

requiring removal of

gallbladder

4 in 1000 procedures Stones are made in your

gallbladder that cause pain

and need to be removed

*Data from the ReCharge Study through the first year after implantation

Serious adverse events that were related to abdominal surgery or treatment with the Maestro

System from the ReCharge Study were neuroregulator disc not working properly, gallbladder

disease, nausea, vomiting, bleeding duration operation, ileus, atelectasis and pain at the disc

site.

7.2.2 Benefits of the Maestro System

The Maestro System was shown to help patients lose weight. Most patients (52.5%) who

received VBLOC therapy in the ReCharge Study lost at least 20% of their excess weight in

comparison to approximately one third of the sham control patients (32.5%). For example, if a

patient was 100 pounds overweight, they lost 20 pounds over one year. Patients also had smaller

waists one year after implantation compared to the start of the study.


Patient Manual


8. Clinical Studies of the Maestro System.

A clinical study of the Maestro System was done with 239 patients who are being followed for

5 years after getting the device. Two out of three patients were in the treatment group. This

group got the Maestro System device and VBLOC Therapy. One out of three was in the control

group which got a sham device that did not deliver VBLOC therapy (placebo). All patients

participated in a weight management program that discussed a healthy diet, exercise, and

behavior changes. Patients did not know if they got the Maestro device or the control device

until after the 12-month follow-up visit.

Adverse Events

The ReCharge Study examined the safety risks of the Maestro System from implant through the

first year. The study looked at the number of patients in the treatment group who had a serious

complication due to using the device or implanting the device. At 12 months, 6 of 162 treatment

patients (3.7%) had a serious complication. This rate was better than expected in the study, The

complications were two cases of device not working correctly, one case of pain at the site of

neuroregulator disc, one case of gallbladder disease, one case of severe vomiting and one case

of lung collapse due to surgery.

There were other serious complications associated with or identified during the surgery itself.

These included 6 cases of nausea after surgery, cirrhosis (liver disease, identified during the

surgery, in a patient who was not implanted with the device), the small intestine temporarily not

working (ileus) and bleeding from a body part that was operated on. One other serious

complication occurred later in the study when a small hole was made in the stomach while

removing the device.

More common complications that were not serious were pain at the neuroregulator disc site,

other kinds of pain, heartburn, abdominal (stomach) pain, nausea, difficulty swallowing, pain

where the doctor made the cuts in the skin to place the device and burping (see table in Risks

and Benefits section). Most complications got better over time and did not require any more

surgery. Some patients had their VBLOC therapy parameters adjusted to help with discomfort

like heartburn and abdominal pain. These changes often helped these symptoms.

Reoperation and Device Removal

There were 9 reoperations due to a complication or the device not working correctly among 8

patients through the first year after implant. An additional 3 of these surgeries occurred between

one and one and 1/2 years after implant.

There were 5 VBLOC-treated patients who had their device explanted in the first year. Two

explants were for subject decision, one for pain at the neuroregulator disc site, one for pain with

therapy, and one for heartburn. An additional 16 patients had their device removed between one

and one and 1/2 years after implant. Twelve explants were for subject decision, one for pain in

arm not related to the device, one for pain at the neuroregulator disc site, and two for abdominal

pain.

Weight Loss through 12 Months


Patient Manual


Patients who received VBLOC therapy with the Maestro device lost more weight than patients

in the control group. Patients who received VBLOC therapy lost an average of 24 pounds in the

first year after implant compared to 16 pounds in the control group. At 12 months, patients in

the Maestro device group had an average of 9.7% total body weight loss (%TBL), compared to

6.4% TBL for the control group.

The table below shows the percent excess weight loss (%EWL), %TBL and actual weight loss

for patients in the Maestro device and control group through the first 12 months of the study.

Percent Excess Weight Loss (%EWL), Total Body Loss (%TBL) and Actual Weight Change in the

ReCharge Study through the first 12 months

VBLOC Sham Control

Mean (SE) Mean (SE)

[95% CI] [95% CI]

Excess Weight Loss (%) 25.75 (1.32) 16.85 (1.94)

[23.16, 28.35] [13.05, 20.65]

Total Body Loss (%) 9.68 (0.50) 6.36 (0.73)

[8.71, 10.65] [4.94, 7.79]

Actual Weight Change (lbs) -24.14 (1.27) -16.07 (1.86)

[-26.62, -21.65] [-19.71, -12.44]

Other Improvements

Patients in both treatment and sham control groups in the study showed improvements in risk

factors related to their obesity, including cholesterol levels, blood pressure, glucose levels and

waist size (see ”Changes in Obesity Risk Factors” table). Both groups also improved their

ability to have better control of their hunger and showed increased feelings of well-being.

Changes in Obesity Risk Factors

Risk Factor

VBLOC Sham Control

Screening

Mean (SD)

Mean Change

from Screening

(SD)

Screening

Mean (SD)

Mean Change

from Screening

(SD)

Cholesterols and Blood Sugars

Total Cholesterol (mg/dL) 204.2 (36.0) -8.7 (29.1) 204.8 (33.2) -9.7 (28.4)

LDL Cholesterol (mg/dL) 121.9 (31.1) -5.2 (26.4) 122.5 (26.7) -4.3 (23.5)

HDL Cholesterol (mg/dL) 54.3 (14.2) 1.0 (9.2) 53.6 (17.0) -0.4 (10.4)

Triglycerides (mg/dL) 141 (61) -21 (58) 151 (97) -33 (61)

Fasting Plasma Glucose (mg/dL) 96.6 (16.8) -1.5 (14.6) 98.4 (30.7) -0.7 (10.1)

HbA1c (%) 5.66 (0.63) -0.33 (0.43) 5.85 (1.30) -0.31 (0.45)


Patient Manual


Risk Factor

VBLOC Sham Control

Screening

Mean (SD)

Mean Change

from Screening

(SD)

Screening

Mean (SD)

Mean Change

from Screening

(SD)

Heart

Systolic Blood Pressure (mmHg) 127.4 (12.4) -5.5 (14.2) 129.5 (13.1) -4.0 (13.5)

Diastolic Blood Pressure (mmHg) 80.7 (9.0) -2.8 (9.6) 81.5 (10.0) -4.5 (8.2)

Heart Rate (bpm) 76.2 (9.6) -3.6 (10.3) 74.8 (10.1) -3.5 (11.5)

Waist Size

Waist Circumference (cm) 121 (12) -10 (10) 123 (11.3) -8 (7)


Patient Manual


Weight Loss through 18 Months

The graph below shows the difference between the Maestro device and control group in percent

excess weight loss (%EWL) and %TBL over the first 18 months of the study. Patients in the

control group lost weight at first but began to regain the weight they lost after the first 12

months of the study.

Average Percent of Excess Weight Loss (%EWL) and Total Body Loss (%TBL) in the ReCharge Study

through 18 months


Patient Manual


9. Turning off your Neuroregulator disc

If you are in a situation where you need to turn your neuroregulator disc off and stop therapy

(e.g. environments with strong magnetic fields or due to discomfort), you can do so by:

1. Connect the transmit coil to the mobile charger and position it over the neuroregulator

disc.

2. With the transmit coil positioned over the neuroregulator disc, press and hold the MC

button on the mobile charger for approximately 60 seconds.

3. The MC status indicator will turn red and start to flash.

If a mobile charger is not available, slowly pass a medical device magnet over the

neuroregulator disc. Medical device magnets are commonly found in hospital emergency

rooms.

After an emergency shutdown, contact your doctor or nurse during normal business hours to

schedule an appointment to restart your therapy and neuroregulator disc.

MC Status Indicator

Flashing Red


Patient Manual


10. Troubleshooting

Issue Recommended Action

MC Status Indicator is a

solid red when checking the

neuroregulator disc

Contact your doctor to schedule a visit to check your


MC Status Indicator is

flashing red when checking

the neuroregulator disc

Contact your doctor to schedule a visit to check your


Transmit Coil indicator

stays on, or constantly

flashes

Try repositioning your coil as described in Section 5. If

the problem persists contact your doctor to see if you

need to replace your patient coil.

MC feels hot when charging

the neuroregulator disc

Some temperature increase is normal. Make sure the MC

is well ventilated. Do not place it in your pocket or other

confined space. If it becomes too hot, stop using it and

allow it to cool before charging again.

MC will not start a charging

session with the

neuroregulator disc

Check to see if the neuroregulator battery indicator shows

5 bars. If 5 bars are shown, the battery is full and does

not need a charge. Also check the MC battery, it may

need to be recharged before charging the neuroregulator

disc

MC Screen is Blank Connect MC to AC recharger and press the MC button

once. If it remains blank for over 30 seconds quickly

disconnect and reconnect the AC recharger power cord.

Refer to Section 5 on charging the MC for more details.

MC low battery indicator

flashes while charging the

neuroregulator disc

Continue your implant charging session until the MC

screen is blank. The MC will continue to provide a

charge to the implant when the low MC battery indicator

is flashing. Refer to Section 5 for more details.

Neuroregulator battery

indicator does not reach full

5 bars

Charge your implant more frequently. Long continuous

charging sessions are best. If the implant battery is too

low you may need to charge twice in one day. Also

ensure your coil position is optimal for charging. Refer

to Section 5 for more details.

Any other issue Contact your doctor.


Patient Manual


11. Your Patient Identification Card

A patient identification card states you have been implanted with the Maestro System medical

device. This card also provides basic information about your system and lists your doctor’s

name and telephone number.

This is helpful when you need to bypass a security system, or during a medical emergency.

Keep this card with you at all times. You will receive a temporary card at the time of surgery

and a laminated card in the mail or at your first follow up visit.


Patient Manual


12. Contact Information

Doctor Contact Information:

Doctor name: ______________________

Phone number: _________________

EnteroMedics Contact Information:

Technical Support: Phone: 1800-MY-VBLOC (1-800-698-2562)

Corporate: EnteroMedics Inc.

2800 Patton Road

St. Paul, MN 55113 USA

www.EnteroMedics.com

Phone: +1 651-634-3003

Fax: +1 651-634-3212

http://www.enteromedics.com/

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