introduction to inspire therapy - ear, nose, throat & plastic surgery associates
TRANSCRIPT
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Training Module #1
Introduction to Inspire Therapy
www.inspiresleep.com
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Program Training Curriculum
2
Module 1:
Introduction
to Inspire
therapy
Module 2:
DISE
Module 3: Prior
authorization
Module 4:
Implant
Module 5: OR
prep
Module 6:
Activation /
titration and
programmer
Who needs
training?
Any AHP or
MD that will
discuss Inspire
therapy with
patients
Physician that
will perform
DISEs
MD and staff
that submit prior
authorizations
Implanting
surgeon(s)
OR staff that
will support
Inspire therapy
implants
Any MD, AHP
or night tech
that will work
programmer at
activation or
titration
Who conducts
the training?
Local Inspire
territory
manager
Inspire
technical
training group
Inspire prior
authorization
team
Inspire
technical
training group
Local Inspire
territory
manager
Inspire
technical
training group
Where is the
training?
At center At center At center Cadaver lab
Tampa or
Phoenix
At center At center
When is the
training
conducted?
Immediately
post selection
(Site Visit or
Kickoff)
Once first
patients have
been screened
and scheduled
for DISE
Once first
patients have
passed DISE
Once site has
two patients
scheduled for
implant
After surgeon
has been
trained and
one week prior
to 1st case
After first
implant and
prior to first
device
activation
Goal: Move through this
process in 6-8 weeks
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Module 1: Introduction to Inspire Therapy
Section 1 – information for health care professionals
• Indications overview
• How Inspire therapy works
• Episode of care overview
• Therapy implementation
Section 2 – “Patient Introduction to Inspire”
• Inspire therapy overview
• Who are good candidates for Inspire therapy
• Patient assessment overview
• Inspire therapy implementation
• Inspire therapy reimbursement Q&A
• Other frequently asked questions from patients
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Section 1:
Inspire Therapy for Healthcare Professionals
• Indications overview
• How Inspire therapy works
• Episode of care overview
• Therapy implementation
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy Indications
• Adults 22 years of age and older
• Diagnosed OSA with an AHI range of 20-65 per hour
• CPAP failure or inability to tolerate CPAP treatment:– PAP failure is defined as an inability to eliminate OSA (AHI of greater than
20 despite PAP usage), and PAP intolerance is defined as:
– Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night).
– Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it).
• Appropriate airway anatomy
Indications Overview
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy Contraindications
• Screening sleep study shows > 25% central+mixed apneas
• Anatomical assessment findings that could compromise the performance
of Inspire such as complete concentric collapse (CCC) at the palate
• Pre-existing conditions that have compromised neurological control of
the upper airway
• Patients who are unable or do not have the necessary assistance to
operate Inspire therapy
• Patients who are pregnant or plan to become pregnant
• Patients who will require MRI
• Patients with another implantable device (ex. pacemaker) should consult
the device manufacture to assess possibility of interaction
Indications Overview
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy Warnings and Precautions
• Body Mass Index ≤ 32
– BMI > 32 may be associated with decreased likelihood of response to
treatment
• Diathermy (primarily used in physical therapy)
– Do not use shortwave diathermy, microwave diathermy or therapeutic
ultrasound diathermy on patients with a neurostimulation system
• MRI can cause tissue damage as well as damage to the Inspire
system and components
• Electromagnetic compatibility and interference (EMI). Extremely
strong sources of EMI could interfere with normal IPG operation
– Electrocautery, irradiation, lithotripsy, RF-ablation, x-ray, and fluoroscopy
are typical EM disturbance sources. Treatments that use ultrasonics,
defibrillation, or radiation can adversely affect the Inspire System.
Indications Overview
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy Overview
• Inspire therapy:– Works inside the body - fully implanted
– Monitors breathing patterns during sleep
– Delivers mild stimulation to key airway
muscles to keep airway open during sleep
– Turned on and off with a handheld
sleep remote
8
Sleep Remote
How Inspire Therapy Works
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Multi-level Mechanism of Action
• Therapeutic effect is evident at both the palate and tongue-base
• More prominent response with increasing stimulation energy – within
therapeutic range
Safiruddin F, et al. Effect of upper-airway stimulation for obstructive sleep
apnoea on airway dimensions. European Respiratory Journal, 2014.
How Inspire Therapy Works
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy – Sleep Study Illustration
Inspire therapy turned on
Severe OSA Events Resolved
Airflow
SpO2
Inspire therapy effect during
polysomnography
Airflow, breathing and normal oxygen levels restored
How Inspire Therapy Works
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Pre Implant – Episode of Care Summary
ENT SurgeonSleep or ENT
Surgeon
A multi-disciplinary team consisting of a sleep physician and ENT
surgeon is responsible for carefully selecting the right patient to
receive Inspire therapy
ScreeningSurgical
ConsultDISE
Insurance Prior Auth.
Implant
Episode of Care Overview
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
What Pre Implant Follow-up is Needed?
• The sleep MD or ENT surgeon should perform all necessary screening activities– pre-implant sleep study, evaluation of indications, patient interest in surgery
• Each patient should undergo a full consultation with the ENT surgeon to discuss the surgery and evaluate their airway
• The ENT surgeon should perform a Drug Induced Sedated Endoscopy (DISE) toassess the airway collapse pattern and to rule out complete concentric collapse at the palate, which is contraindicated
• Once the patient has been properly screened and assessed, a prior authorization for payment of benefits will be submitted to the patient’s insurance company typically by the ENT surgeon’s office
• Once a determination of benefits coverage (prior authorization) has been approved, the patient will be scheduled for an Inspire system implant
ScreeningSurgical
ConsultDISE
Insurance Prior Auth.
Implant
Episode of Care Overview
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Post Implant – Episode of Care Summary
A multi-disciplinary team consisting of an sleep physician and ENT
surgeon is responsible for therapy activation and long term care
follow up
Post-op CheckTherapy
ActivationPhone
CallSleep Study
Regular Follow Up
Sleep PhysicianSleep or ENT Surgeon
Episode of Care Overview
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
What Post Implant Follow-up is Needed?
• The ENT surgeon should examine the incisions and healing process 7-10 days following implant– NOTE: Inspire therapy is still de-activated
• 1 month after implant, the physician will activate Inspire therapy for the first time
• 1 week following activation, the patient should be called to assess the acclimation process
• ~1 month after activation, the patient will undergo an in-lab sleep study titration to optimize Inspire therapy parameters
• Regular follow up visits are recommended every 6-12 months
Post-op CheckTherapy
ActivationPhone
CallSleep Study
Regular Follow Up
Episode of Care Overview
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Patient Follow Up With Inspire Therapy- Module 6 training will be conducted after the 1st implant -
Physician Tablet
Programmer Bag
The physician tablet allows the provider to:
– Program Inspire therapy settings wirelessly
– Monitor and track Inspire adherence
– Reporting capabilities & troubleshooting
Episode of Care Overview
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Patient Response Curves
16
OS
A S
eve
rity
Rapid, durable responder Slow-but-sure responder Partial-to-non responder
Implant /
Activation
2-3 Month
Titration1 Year Long Term
Curves are approximations
Most
patients
• Ideally centers should have 10 implanted patients followed at 6 months before assessing overall therapy effectiveness
• Some patients will require advanced titration methods• Regardless of curve the goal for all patients is “all night every night” usage
Therapy Implementation
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Therapy Outcome Drivers
• Patient selection
– BMI > 32
• Decreased likelihood of response
• Increased complexity of implant
– OSA type
• Greater than 25% central sleep apnea patients are not indicated
– DISE to screen out patients with CCC at the palate
• Sedation level is critical, must closely mimic sleep
• Electrode placement / implant technique
– Optimal tongue motion
– Minimal disruptive dissection of nerve and supporting structures
Therapy Implementation
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Section 2: Patient Introduction to Inspire
• Inspire therapy overview
• Good candidates for Inspire therapy
• Patient visit overview
• Inspire therapy questions and answers
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Patient Introduction to Inspire
19
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy Overview
• Inspire therapy:– Works inside the body - fully implanted
– Monitors breathing patterns during sleep
– Delivers mild stimulation to key airway muscles to keep airway open while you are sleeping
– Turned on and off with a handheld sleep remote
20
Sleep Remote
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Therapy History
• Over 100,000 patients each year receive an implantable
neuro-stimulation system for various medical conditions
• Inspire therapy is a neuro-stimulation system for sleep
apnea and was developed at Medtronic
• Over 40 leading medical centers are currently qualified
and trained to treat patients with Inspire therapy
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
How Does Inspire Therapy Work?
Inspire therapy keeps your airway open while you sleep
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy – Sleep Study Illustration
Inspire OFF
A four minute snapshot while therapy is being turned on
Inspire ON
Airflow
Breathing
Effort
Oxygen
Severe OSA Airflow, breathing and normal oxygen
levels restored
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy Performance Was Evaluated In The
STAR Clinical Trial
• 126 patients who struggled with CPAP received Inspire therapy
• Results were published in the New England Journal of Medicine
Results at 1 year:
• 86% of patients reported using the therapy every night
• On average, patients experienced a 70% decrease in their sleep apnea events
• 85% of patients showed improvement in their quality of life measures
• 85% of bed partners reported “no or soft snoring”
Sources:
• Upper-airway Stimulation for Obstructive Sleep Apnea, Strollo PJ Jr, Soose RJ, Maurer JT et al. N Eng J Med. 2014;370(2):139-149
• Inspire STAR clinical database
There were no unanticipated adverse events - only two events required surgical intervention. Both involved repositioning the
generator – procedures performed under local anesthesia.
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy Patient Profile
• Diagnosed with obstructive sleep apnea (AHI 20-65)
• Struggle to get consistent benefit from CPAP
• Have a compatible airway anatomy profile
• Have a body mass index (BMI) ~32 or less
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy Visits
Routine
Follow-ups
Sleep profile(May require a new sleep study)
Anatomy check(Requires a sedated endoscopy)
Typically
outpatient
Assessment ImplantAfter Implant
Therapy
activation
Therapy
optimization(Requires a sleep study)
Annual check up
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Inspire Therapy Surgery Overview
• Typically an outpatient procedure
– Most patients return to home the same day
– General anesthesia
• Three small incisions
– Expect some pain & swelling at the incision sites for a few days after
surgery
• Recovery time of ~ 2 weeks
– A return to normal non-strenuous activities occurs within a few days
– The surgeon will evaluate the healing process after one week
– Strenuous activity should be avoided for about two weeks
• Most patients take Tylenol for post surgery pain if needed
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
How Do You Control Inspire Therapy?
• You have complete control of Inspire
therapy with your personal sleep remote:
– Turn Inspire ON or OFF
– Pause therapy
– Adjust the level of stimulation
• Each night, you use the sleep remote to
turn Inspire therapy on before going to
sleep and off when you wake up
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
What Does Inspire Therapy Feel Like?
Stimulation Off
Mild
Stimulation
• Inspire therapy delivers
mild stimulation to key
airway muscles
• Patients describe feeling
a mild contraction or
tingling sensation in the
tongue when first
activating Inspire
therapy
• Therapy is adjustable for
patient comfort
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Starting with Inspire Therapy
• Most patients get used to Inspire
therapy within the first week
• Therapy levels can be adjusted by the
patient
• In the STAR trial, at 1 year follow-up,
86% of patients reported using Inspire
therapy every night
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Is Inspire Therapy Covered by Insurance?
• This approach has been successful and we are
committed to helping each patient with the
process
• You do not need to have prior approval from
your insurance company for the therapy before
your first clinic visit
• Inspire therapy is FDA approved and proven to be effective in
treating obstructive sleep apnea
• Currently, the therapy is reviewed and approved by insurance
companies on a patient by patient basis
• We will work with Inspire (the company which developed the
therapy) on your behalf to gain payment approval
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Will You Have Out of Pocket Expenses?
• Each insurance plan is different
• In general, the co-pay for Inspire therapy should be similar to co-pays for other surgical procedures
• You may also have secondary benefits or supplemental coverage that will offset your co-pay
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Incisions After Healing is Complete
Incision and device
under collar boneIncision on neck
for stimulation lead
Incision on chest
for sensor lead
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
How Do Physicians Monitor & Program Inspire Therapy?
Physician Tablet
The physician tablet enables wireless communication and programming
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Common Questions About Inspire Therapy
• How long will the battery last?
• ~8-11 years
• Once the battery runs out, the generator
will be replaced with a routine procedure
• How often should a doctor check the
Inspire system?
• The system should be checked 1-2
times per year
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Common Questions About Inspire Therapy
• Are there any medical technologies
that should be avoided?
– MRI scanners may cause harm to
components of the Inspire system and
may also cause tissue damage. Other
imaging technologies like CT-scan and
ultrasound are safe to use.
• How about microwave ovens and other
common household appliances?
– Any common household appliances that
do not emit a strong magnetic field are fine
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A 37
As with any surgically implanted device, there are risks associated with the Inspire
system. First, there are risks related to the surgical procedure itself such as pain,
swelling, temporary tongue weakness, and infection. These types of events are
risks with any kind of surgery, and almost all of them resolve on their own or with
medication within a period of weeks or months.
Once the therapy is turned on, some patients may experience discomfort from
stimulation, tongue abrasion, mouth dryness, and discomfort from the presence of
the device. The majority of these events resolve either on their own, with
medication, or by adjusting the therapy settings. Inspire therapy may not work for
everyone. Your doctor may need to take additional steps to address your sleep
apnea.
Patients with Inspire therapy will not be able to have an MRI. Other imaging
modalities are OK.
Risk Considerations
© Inspire Medical Systems, Inc. 2015 All Rights Reserved
800-115-001, Rev A
Patient Education Materials
38
Tri-fold 8½ x 11
www.InspireSleep.com