Halyard Health, a company out of Alpharetta, Georgia, landed FDA clearance for its COOLIEF Cooled Radiofrequency technology to be used for treatment of moderate to severe chronic knee pain arising from osteoarthritis. It may be particularly beneficial for patients who are poor candidates for knee replacements or that may choose to wait for whatever reason. This is the first radiofrequency (RF) therapy that has been cleared by the FDA for pain relief in osteoarthritic knees. Halyard believes that its system may help many patients avoid drugs and steroid injections, that come with their unique side effects and potential for addiction.
COOLIEF delivers RF energy onto targeted nerves while using cold water to cool the surrounding area. This provides the ability to deactivate nerves while avoiding unwanted damage to nearby tissues.
Here’s some info about the study that led to this regulatory green light:
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 procedure. At baseline, 67.1 percent of the cooled RF group and 62.7 percent of the steroid injection group reported symptoms of severe arthritis. 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 point.
Here’s a video of the procedure:
Product page: COOLIEF Knee Cooled Radiofrequency…
Via: Halyard Health…