The US Food and Drug Administration (FDA) has cleared for marketing the COOLIEF Cooled Radiofrequency (RF) thermal treatment device for knee osteoarthritis (OA), according to a press release published by Halyard Health.1
Halyard Health, a medical technology company that specializes in products to eliminate pain, speed recovery, and prevent infections, developed Cooled RF, a thermal treatment for the relief of chronic, moderate to severe knee pain caused by osteoarthritis.
Cooled RF treatment is an outpatient procedure that uses RF energy to target sensory nerves that cause knee pain in patients with OA , according to a press release on the treatment.2 Cooled RF circulates water through the device to heat the pain-causing nerves and nerve tissue.
The FDA clearance for marketing comes after completion of a prospective, randomized, multicenter study3 that compared Cooled RF with intra-articular steroid injections in 151 patients with OA knee pain.
The researchers noted that 67.1% of the Cooled RF group and 62.7% of the steroid injection group reported symptoms of severe arthritis. At 6 months following the procedure, only 5.2% of the Cooled RF group reported the same severity while 37.3% of the steroid injection group reported the same level of severity as measured by the Oxford Knee Score.
The results of the study showed that in 74.1% of patients receiving Cooled RF treatment, pain was reduced by at least 50% by 6 months post-procedure. At 12 months post-procedure, pain was reduced by 50% in 65.4% of those patients.
The Halyard press release recommends Cooled RF as a treatment alternative to surgery, nonsteroidal anti-inflammatory drugs, opioids, and steroid injections.
“Many OA patients try unsuccessfully for years to treat their chronic knee pain with conservative pain therapies before turning to surgery,” said Lisa Kudlacz, vice president and general manager, Global Interventional Pain, Halyard Health, in the press release. “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 year.”
FDA clears Halyard Health’s COOLIEF* for the management of osteoarthritis knee pain (press release). Alpharetta, Georgia: Halyard. Published April 20, 2017. Accessed April 20, 2017.
COOLIEF Knee Cooled Radiofrequency: A non-surgical, non-narcotic procedure for chronic knee pain (press release). Alpharetta, Georgia: Halyard. Published May 8, 2015. Accessed April 20, 2017.
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.