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Devices Orthopaedic FDA

 News Release - April 20, 2017

FDA Clears Halyard Health's COOLIEF for the Management of Osteoarthritis Knee Pain

The First and Only Radiofrequency Treatment Cleared for Relief from Chronic Osteoarthritis Knee Pain

LAS VEGAS, April 20, 2017 -- (Healthcare Sales & Marketing Network) -- American Society of Interventional Pain Physicians Annual Meeting, Booth #407 -- Halyard Health (NYSE: HYH), a medical technology company focused on eliminating pain, speeding recovery and preventing infection, today announced the U.S. Food and Drug Administration (FDA) has cleared for marketing its COOLIEF* Cooled Radiofrequency (Cooled RF) thermal treatment for the relief of chronic moderate to severe knee pain caused by osteoarthritis (OA). The first and only RF treatment to be cleared specifically to relieve OA knee pain, COOLIEF RF is a minimally invasive, thermal radiofrequency pain management system using water-cooled technology to safely deactivate pain-causing sensory nerves.

This new clearance is based on results from a 151-patient prospective, randomized multi-center study comparing COOLIEF Cooled RF to intra-articular steroid injections in patients suffering from knee pain due to osteoarthritis. In 74.1 percent of the cooled RF patient group, pain was reduced by at least 50 percent at six months and maintained in over 65.4 percent of those patients for a full 12 months post procedure1,2. At baseline, 67.1 percent of the cooled RF group and 62.7 percent of the steroid injection group reported symptoms of severe arthritis1,2. Results indicate that six months post-procedure, only 5.2 percent of the cooled RF group reported the same severity level versus 37.3 percent of patients treated with steroid injections, as measured by the Oxford Knee Score1. In addition, the cooled RF patient group's Oxford Knee Score remained low for 12 months with only 11.5 percent reporting severe symptoms at that point1. The Oxford Knee Score is a validated outcomes instrument designed to assess function and pain associated with the knee1.

"I see many patients who suffer with chronic osteoarthritis knee pain in my practice who are not immediate candidates for knee replacement surgery due to co-morbidities, such as obesity or other chronic health issues," said Dr. Timothy Davis, founder and medical director, Orthopedic Pain Specialists, and investigator in the recent study. "COOLIEF Cooled RF treatment provides significant pain relief for patients with OA of the knee until they are able to undergo surgery. Until now there have been few options available for my patients."

According to the Centers for Disease Control and Prevention, OA affects over 30 million adults in the U.S. and is caused by the damage and breakdown of cartilage between bones that can lead to joint pain, swelling and stiffness3. The prevalence of OA is on the rise as both the age and weight of Americans continue to increase4. As cases of OA increase, so do associated economic costs including treatment, adaptation of lives and homes to help patients manage pain caused by the disease, and lost work productivity5.

Surgery can be beneficial in properly selected patients, but due to BMI, age, co-morbidities, invasiveness or lack of necessary support systems, some patients are either not candidates for surgery, or are forced to delay surgery6. Patients suffering from chronic knee pain wait an average of nine years until they are ready or qualify for surgery6.

Prior to surgery, initial treatments for knee pain often include nonsteroidal anti-inflammatory drugs, opioids and steroid injections. Medication provides only short-term relief and comes with serious risks, which include opioid abuse and dependence7. According to the Mayo Clinic, one in four patients prescribed opioid painkillers is at risk to progress to episodic or long-term prescription use8. Healthcare providers are becoming more conservative in the use of opioids to reduce associated complications such as nausea, respiratory depression, and even death9,10,11. Steroid injections can provide relief for months at a time, but may have to be repeated for continued pain relief6.

"Many OA patients try unsuccessfully for years to treat their chronic knee pain with conservative pain therapies before turning to surgery. This treatment is clinically proven to be significantly more effective in relieving OA knee pain, increasing functionality, and decreasing the need for pain medication for up to a year1," said Lisa Kudlacz, vice president and general manager, Global Interventional Pain, Halyard Health. "The U.S. consumes an astounding 80 percent of the global opioid supply with only five percent of the population7,12. At Halyard we are committed to helping curb the opioid epidemic by providing solutions that help patients manage pain without the risk of addiction."

To learn more about COOLIEF, please visit http://www.halyardhealth.com/chronicpain.

About Halyard Health

Halyard Health Inc. (NYSE: HYH) is a medical technology company focused on eliminating pain, speeding recovery and preventing infection for healthcare providers and their patients. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today's most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery and preventing healthcare-associated infections. Halyard's business segments - Medical Devices and Surgical and Infection Prevention (S&IP) - develop, manufacture and market clinically superior solutions that improve medical outcomes and business performance in more than 100 countries. For more information, visit www.halyardhealth.com.

*Registered Trademarks or Trademarks of Halyard Health, Inc. or its affiliates.

1 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 Halyard.

2 Davis T. Cooled RF Ablation Superior to Corticosteroids in Knee Osteoarthritis. Pain Medicine News [Internet]. 2017Feb2; Available from: http://www.painmedicinenews.com/Multimedia/Article/02-17/Cooled-RF-Ablation-Superior-to-Corticosteroids-in-Knee-Osteoarthritis/40262/ses=ogst?enl=true 3Osteoarthritis Fact Sheet [Internet]. CDC.gov. Centers for Disease Control and Prevention; 2017 [cited 2017Apr12]. Available from: https://www.cdc.gov/arthritis/basics/osteoarthritis.htm

4 Bliddal H, Christensen R. The treatment and prevention of knee osteoarthritis: a tool for clinical decision-making. Expert Opinion on Pharmacotherapy. 18 June 2009; 10(11):1793-804.

5 Altman RD. Early Management of Osteoarthritis. Am J Manag Care. 2010;16 (Suppl Management):S41-47.[PubMed]

6 KS&R. Halyard sponsored study: Osteoarthritis Pain Landscape & Patient Journey. 2015. Data on file.

7 AAOS - American Academy of Orthopedic Surgeons. Opioid Use, Misuse, and Abuse in Orthopaedic Practice. Information Statement 1045. http://www.aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/advistmt/1045%20Opioid%20Use,%20Misuse,%20and%20Abuse%20in%20Practice.pdf Published October 2015.

8 Mayo Clinic. "One in four people prescribed opioids progressed to longer-term prescriptions." ScienceDaily, July 1, 2015. www.sciencedaily.com/releases/2015/07/150701115325.htm

9 Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, et al. Relationship Between Pain and Opioid Analgesics on the Development of Delirium Following Hip Fracture. Journal of Gerontology. 2003;58A(1):76–81.

10 Sieber FE, Mears S, Lee H, Gottschalk A. Postoperative Opioid Consumption and Its Relationship to Cognitive Function in Older Adults with Hip Fracture. Journal of the American Geriatrics Society. 2011Dec;59(12):2256–62.

11 Riddell M, Ospina M, Holroyd-Leduc JM. Use of Femoral Nerve Blocks to Manage Hip Fracture Pain among Older Adults in the Emergency Department: A Systematic Review. CJEM. 2016Jul;18(4):245–52.

12 American Society of Interventional Pain Physicians. Fact Sheet


Source: Halyard Health

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