FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Green Lights Halyard Health's Coolief for the Management of Osteoarthritis Knee Pain

April 21, 2017
A A

Alpharetta, GA-based Halyard Health has received FDA marketing clearance for its Coolief cooled radiofrequency thermal treatment for the relief of chronic moderate to severe knee pain caused by osteoarthritis.

The device is a minimally invasive, thermal radiofrequency pain management system using water-cooled technology to safely deactivate pain-causing sensory nerves.

The clearance was based on clinical results of 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 procedure.

Osteoarthritis affects more than 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 stiffness. — Cynthia Jessup

View today's stories