FDA clears Halyard ’ s Coolief RF device for treating OA pain

Halyard Health (NYSE:HYH) said today it won FDA clearance for its Coolief cooled radiofrequency thermal system designed for treating moderate to severe chronic osteoarthritis knee pain The Alpharetta, Ga.-based company claims that the Coolief is the 1st and only RF treatment to be cleared by the FDA for relieving OA pain. “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. 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,” study investigator Dr. Timothy Davis of Orthopedic Pain Specialists said in a prepared statement. Clearance came based on results from a 151-patient prospective, randomized trial comparing the Coolief system to intra-articular steroid injections in patients suffering from OA knee pain. Results indicated that 74.1% of participants treated with the Coolief system reported pain reduced by at least 50% at 6 months. Of those patients, 65.4% reported continued pain reduction at 12 months post procedure. Initially, 67.1% and 62.7% of the Coolief and control participants reported severe arthritis symptoms, respectively. At 12 months, only 5.2% of Coolief patients reported similar levels of symptoms, versus 37....
Source: Mass Device - Category: Medical Equipment Authors: Tags: Orthopedics Pain Management Regulatory/Compliance Halyard Health Source Type: news

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