coolief* cooled rf: coolief cooled radiofrequency …...coolief* cooled rf fills the gap between...

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Finally, physicians can manage long-term relief of OA knee pain with an ultrasound-guided procedure that is: Minimally invasive Non-narcotic Clinically proven to provide up to 12 months of pain relief 1 Learn more about how COOLIEF* Cooled RF can fit into your treatment algorithm for chronic OA knee patients. extendpainrelief.com 2001. FDA Clearance of Pain Management Generator 2013. Hip and Knee Modalities Launched 2014. Multi-Cooled Radiofrequency Launched 2017. FDA cleared to treat OA Knee pain 2018. Cooled RF of the Knee Technique Utilizing Ultrasound Guidance CRK-17-50-4 1 Probe 3 Introducers 2 Tube Kits CRK-17-75-4 1 Probe 3 Introducers 2 Tube Kits MCK2-17-50-4 2 Probes 4 Introducers 2 Tube Kits MCK2-17-75-4 2 Probes 4 Introducers 2 Tube Kits MCK3-17-50-4 3 Probes 6 Introducers 2 Tube Kits MCK3-17-75-4 3 Probes 6 Introducers 2 Tube Kits Product Code Description Packaging COOLIEF* Cooled RF Kits Specifically Designed for Knee Modality COOLIEF * COOLED RADIOFREQUENCY (RF): NEW ULTRASOUND GUIDED TECHNIQUE FOR OSTEOARTHRITIS KNEE PAIN If you have an ultrasound unit, you can perform ultrasound-guided, COOLIEF* Cooled RF. Benefits include: No radiation Real-time guidance Soft tissue visualization (including effusions) Doppler (genicular nerve visualization) COOLIEF* Cooled RF: A proud history of firsts GET YOUR P∆TIENTS B∆CK TO THE THINGS TH∆T M∆TTER FDA CLEARED for OA knee pain! References: 1. Davis T. Study: Cooled RF Ablation Superior to Corticosteroids in Knee Osteoarthritis. Pain Medicine News 2017 Feb. 2. Halyard Health Inc. sponsored study: A Prospective, Multi-Center, Randomized, Clinical Trial Evaluating the Safety and Effectiveness of Using COOLIEF™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing Corticosteroid Injection in the Management of Knee Pain. Final results 03Apr2017. Study available upon request from Avanos. *Registered Trademark or Trademark of Avanos Medical, Inc., or its affiliates. © 2018 AVNS. All rights reserved. COPY-02916

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Page 1: COOLIEF* Cooled RF: COOLIEF COOLED RADIOFREQUENCY …...COOLIEF* Cooled RF fills the gap between short-term pain relief and surgery. COOLIEF* Cooled RF – the first cooled RF treatment

Finally, physicians

can manage long-term

relief of OA knee pain

with an ultrasound-guided procedure that is: • Minimally invasive• Non-narcotic• Clinically proven to

provide up to 12 months of pain relief1

Learn more about how COOLIEF* Cooled RF can fit into your treatment algorithm

for chronic OA knee patients.

extendpainrelief.com

2001. FDA Clearance of Pain Management Generator

2013. Hip and Knee Modalities Launched

2014. Multi-Cooled Radiofrequency Launched

2017. FDA cleared to treat OA Knee pain

2018. Cooled RF of the Knee Technique Utilizing Ultrasound Guidance

CRK-17-50-4 1 Probe 3 Introducers 2 Tube Kits

CRK-17-75-4 1 Probe 3 Introducers 2 Tube Kits

MCK2-17-50-4 2 Probes 4 Introducers 2 Tube Kits

MCK2-17-75-4 2 Probes 4 Introducers 2 Tube Kits

MCK3-17-50-4 3 Probes 6 Introducers 2 Tube Kits

MCK3-17-75-4 3 Probes 6 Introducers 2 Tube Kits

Product Code Description Packaging

COOLIEF* Cooled RF Kits Specifically Designed for Knee Modality

COOLIEF* COOLED RADIOFREQUENCY (RF): NEW ULTRASOUND GUIDED TECHNIQUE FOR OSTEOARTHRITIS KNEE PAINIf you have an ultrasound unit, you can perform

ultrasound-guided, COOLIEF* Cooled RF.Benefits include: • No radiation• Real-time guidance• Soft tissue visualization (including effusions) • Doppler (genicular nerve visualization)

COOLIEF* Cooled RF: A proud history of firsts

GET YOUR P∆TIENTS B∆CK TO THE THINGS TH∆T M∆TTER

FDA CLEARED fo

r

OA knee pain!

References: 1. Davis T. Study: Cooled RF Ablation Superior to Corticosteroids in Knee Osteoarthritis. Pain Medicine News 2017 Feb. 2. Halyard Health Inc. sponsored study: A Prospective, Multi-Center, Randomized, Clinical Trial Evaluating the Safety and Effectiveness of Using COOLIEF™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing Corticosteroid Injection in the Management of Knee Pain. Final results 03Apr2017. Study available upon request from Avanos.

*Registered Trademark or Trademark of Avanos Medical, Inc., or its affiliates. © 2018 AVNS. All rights reserved. COPY-02916

Page 2: COOLIEF* Cooled RF: COOLIEF COOLED RADIOFREQUENCY …...COOLIEF* Cooled RF fills the gap between short-term pain relief and surgery. COOLIEF* Cooled RF – the first cooled RF treatment

COOLIEF* Cooled RF fills the gap between short-term pain relief and surgery.

COOLIEF* Cooled RF – the first cooled RF treatment for chronic OA knee pain – is now the first to bring ultrasound-guided cooled RF to the knee

RF energy creates targeted lesion that ablates and deactivates sensory nerves while leaving motor nerves intact.

† Patients with patellofemoral compartment symptoms potentially could be candidates for the 4th lesion – Suprapatellar Genicular Nerve - provided they respond well to the diagnostic block.‡ The “Cooled RF Set Temp” (Default Setting T = 60°C) displayed on the COOLIEF* RF Generator refers to the cooled electrode temperature and does not reflect the immediate surrounding tissue temperature. The heat generated from the radiofrequency energy produces thermal energy with average maximum tissue temperatures greater than 80°C.

§When compared to Stryker 20 ga standard RF lesion based upon testing conducted by Avanos and compared to Stryker’s published information.

Clinical Data§ supports COOLIEF* Cooled RF for treatment of OA knee pain2

How COOLIEF*Cooled RF works

Randomized level-one, multi-center study with 151 patients over twelve months with primary effectiveness at six and twelve months.

Water-cooled energy is delivered through RF electrodes.

Radiofrequency generator transmits small current through insulated electrode.

The Ultrasound Knee technique for COOLIEF* Cooled RF has 3 target locations with the 4th location being optional. The technique for the diagnostic block under ultrasound is the same as the technique for COOLIEF* Cooled RF of the knee. Target Locations:• Superior Medial Genicular Nerve• Superior Lateral Genicular Nerve• Inferior Medial Genicular Nerve• Suprapatellar Genicular Nerve

(Optional 4th Lesion)†

Mod

erat

e

16.922.4

16.7

35.7

NRS PAIN SCORE2

6 months post-procedure, patients reported ≥ 50% pain relief: • 74% of COOLIEF* group• 16% of IAS group

12 months post-procedure, 65% of COOLIEF* Cooled RF patients reported ≥ 50% pain relief.• 85% of the IAS group switched to COOLIEF* Cooled RF at 6 months

Baseline

Baseline

6 Months

6 Months

12 Months

12 Months

2019

3029

4039

48

Exce

llent

Goo

dPo

or

0

0

5

10

7.3

2.5

3.1

7.2 5.9

The 11-point NRS consists of a scale from “0” to “10” points, with “0” indicating “no pain” and “10” being “worst pain imaginable”. A treatment “responder” experienced a clinically-significant change in pain indicated by an NRS score decrease ≥ 50% relative to the respective baseline.

At baseline, patients reporting severe OA:• 67% of the COOLIEF* Cooled RF group• 63% of the IAS group

6 months post-procedure, patients reporting severe OA:• 5% of the COOLIEF* Cooled RF group• 37% of the IAS group

OKS measured study subjects’ knee function based on a scale from 0 to 48 points, with knee arthritis becoming less severe as score values increase.

OXFORD KNEE SCORE2

The COOLIEF* Cooled RF Generator and Pump

Up to12 MONTHS

of painrelief1

FDA CLE

ARED for

OA knee pain!

DURA

TIO

N O

F PA

IN R

ELIE

F

Anti- Inflammatory Medications

Prescription Opioids

Steroid Injections

HyaluronicAcid

Injections

Surgery

SHORT-TERM PAIN RELIEF SOLUTIONS

— Hours

— Months

— 1 Year

Treatment AlgorithmDEACTIVATED PAIN SIGNALS

COOLIEF* COOLED RF

5XLARGER LESION THAN STANDARD RF‡

or greaterBEYOND PROBE’S TIP

45%

80Oc

60Oc

ANGLE INDEPENDENCE

COOLIEF*Cooled RF