FDA Clears Halyard Health's COOLIEF* For Management Of Osteoarthritis Knee Pain

Halyard Health, 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 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 Score. 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. The Oxford Knee Score is a validated outcomes instrument designed to assess function and pain associated with the knee.

"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," says 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."

(Image credit: Halyard Health)

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 stiffness. The prevalence of OA is on the rise as both the age and weight of Americans continue to increase. 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 productivity.

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 surgery. Patients suffering from chronic knee pain wait an average of nine years until they are ready or qualify for surgery.

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 dependence. According to the Mayo Clinic, one in four patients prescribed opioid painkillers is at risk to progress to episodic or long-term prescription use. Healthcare providers are becoming more conservative in the use of opioids to reduce associated complications such as nausea, respiratory depression, and even death. Steroid injections can provide relief for months at a time, but may have to be repeated for continued pain relief.

"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 year," 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 population. At Halyard we are committed to helping curb the opioid epidemic by providing solutions that help patients manage pain without the risk of addiction."