GET YOUR PATIENTS BACK TO THE THINGSTHAT MATTER.
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.3. Stelzer W. MD, Use of Radiofrequency Lateral Branch Neurotomy for the Treatment of Sacroiliac Joint-Mediated Low Back Pain: A Large Case Series. Pain Medicine,2013 Jan (1)29-35. 4. Malik, A. et al. Percutaneous Radiofrequency Lesioning of Sensory Branches of the Obturator and Femoral Nerves for the Treatment of Non-Operable Hip Pain. Pain Physician. 2003;6:499-502
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
2019 Shoulder Modality Launched
COOLIEF* COOLED RF:A proud history of firsts
KNEE PAIN?REGAIN! HELP YOUR OA PATIENTS GET ACTIVE AGAIN.
Introducing COOLIEF* Cooled Radiofrequency for longer-lasting relief of osteoarthritis knee pain
The COOLIEF* Cooled RF ULTRASOUND guided technique targets the genicular nerves outside the articular capsule and reduces amount and time of fluoroscopic exposure.
OA knee pain patients experiencing sub-optimal outcomes with alternatives therapies such as arthroscopic debridement or injections are not always candidates for more invasive procedures due to age, BMI, or other comorbidities.
COOLIEF* Cooled RF technology is designed to treat the complex anatomy of variable nerve courses through the creation of large volume spherical lesions.
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
COOLIEF* Cooled RF for Knee PainBenefits include:• No radiation• Real-time guidance• Soft tissue visualization (including effusions)• Doppler (genicular nerve visualization)
Ask about our other COOLIEF* Cooled RF Modalities:Clinical studies of COOLIEF* Cooled RF addressing other sources of pain have demonstrated up to 24 months pain relief with improved physical function and a reduction in pain medication usage.³, ⁴
COOLIEF* Cooled RF for Hip Pain: COOLIEF* Cooled RF for Shoulder Pain:
Designed to treat complicated and variable nerve courses such as the articular innervation of the hip through the creation of large volume, spherical lesions.
Treats chronic shoulder pain through the creation of large volume, spherical lesions.
Learn more about how COOLIEF* Cooled RF can fit into your treatment algorithm for chronic OA knee patients. CooliefForOrthos.com
avanospainmanagement.com
*Registered Trademark or Trademark of Avanos Medical, Inc., or its affiliates. © 2019 AVNS. All rights reserved.COPY-03926
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Treatment Options for Osteoarthritis Knee Pain Have Expanded, Providing Patients Long-Term Relief.
COOLIEF* COOLED RF-FDA CLEARED FOR OA KNEE PAIN
CLINICAL DATA SUPPORTS COOLIEF* COOLED RF FOR TREATMENT OF OA KNEE PAIN Provides patients with longer lasting and more effective pain relief than intra-articular steroid injections2
Orthopedic and Sports Medicine Physicians now have a long-lasting solution to fill the gap in the treatment algorithm.
THE TREATMENT CHALLENGETotal knee replacement isn’t always an option for up to 60% of patients with osteoarthritis (OA) knee pain due to BMI, age, invasiveness and other factors, including the amount of time needed for rehabilitation and recovery. Because of this, patients often will endure pain for 9 years, or longer, until surgery becomes the only option remaining.
Managing patient OA knee pain can be a challenge with today’s limited treatment algorithm, as injections and medications only provide short-term relief.
COOLIEF* Cooled RF is the first and only radiofrequency treatment FDA-cleared for the relief of Osteoarthritis knee pain.
COOLIEF* Cooled RF is a non-surgical, non-narcotic, thermal radiofrequency pain management system that uses water cooled technology to safely deactivate pain-causing sensory nerves.
Clinically proven to provide up 12 months of pain relief.1
New ULTRASOUND guided procedure for the relief of Osteoarthritis knee pain
Intra-articular steroid injections have been shown to decrease in effectiveness after 3-4 weeks, and after multiple injections.
Unable to recommend for or against the use of intra-articular (IA) corticosteroids for patients with symptomatic osteoarthritis of the knee.*
Cannot recommend using hyaluronic acid for patients with symptomatic osteoarthritis of the knee.*
The COOLIEF* Cooled Radiofrequency Generator transmits a small current of RF energy through an insulated electrode placed within the knee’s tissue
The electrode delivers water-cooled energy through RF electrodes
This RF energy creates a targeted lesion that ablates and deactivates the sensory nerves responsible for sending pain signals to the brain, while leaving motor nerves intact to preserve function.
1 2 3
HOW COOLIEF* Cooled Radiofrequency (RF) WORKS
According to the AAOS Treatment of Osteoarthritis of the Knee Guidelines, 2nd Edition, 2013 :
NRS PAIN SCORE
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
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 SCORE
COOLIEF
Baseline
7.3 7.2
33.9
2.8
5.2
2.5
5.9
3.1
1 Month 3 Months 6 Months 12 Months
Mea
n N
RS S
core
8
7
6
5
4
3
2
1
0
IAS COOLIEF
Effective Long Term Pain ReductionCOOLIEF Demonstrates Significant & Durable Results
IAS
Baseline 1 Month 3 Months 6 Months 12 Months
Mea
n N
RS S
core
40
35
30
25
20
15
10
5
0
Improved Physical FunctionSustained Improvement in Oxford Knee Score
COOLIEF IAS COOLIEF IAS
16.7 16.9
33.329.4
35.733.5
22.4
34.6
24.6
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
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