Is Coolief Radiofrequency Treatment Approved by the FDA?

Medtronic recently announced that the FDA approved its diamond-controlled temperature irrigated radiofrequency ablation system for the treatment of paroxysmal atrial fibrillation that does not respond to drug therapy. This procedure, known as ARF, is an attractive alternative for patients who experience problems caused by benign thyroid nodules. It is a safe and FDA-approved procedure, with less pain, less downtime, and no scarring. ARF is a breakthrough in the treatment of symptoms related to thyroid nodules, as it offers long-lasting effects. The Food and Drug Administration (FDA) recently approved the first and only radiofrequency (RF) treatment specifically designed to relieve chronic knee pain due to osteoarthritis.

Marketed by Halyard Health as Coolief, this new procedure uses minimally invasive needles and water-cooled electrodes that emit cooled RF energy to disable the sensory nerves responsible for sending pain signals to the brain. The FDA authorized Coolief based on a multicenter study of 151 patients, of whom 74.1 percent reported a reduction in pain of at least 50 percent after six months; 65.4 percent of patients reported maintaining the same level of pain relief 12 months after undergoing treatment. Six months after the procedure, only 5.2 percent of the chilled RF group reported the same level of pain severity compared to 37.3 percent of patients treated with steroid injections, as measured by the Oxford Knee Score. For most, initial treatments for osteoarthritis include conservative modalities such as physical therapy, non-steroidal anti-inflammatory drugs, opioids, and steroid injections. These may provide relief for only a short time of 6 to 12 weeks in the case of steroid injections and may have side effects or increase the risk of drug dependence.

The Coolief procedure presents a viable alternative and could provide up to 12 months of relief, depending on how quickly the target nerve cells regenerate. According to the Centers for Disease Control and Prevention, osteoarthritis affects more than 30 million adults in the United States and is caused by damage and rupture of cartilage between bones that can lead to joint pain, swelling, and stiffness. A durable solution to pain relief is to have knee replacement surgery, but not all patients are immediate candidates for surgery due to comorbidities such as diabetes or patient preference. Coolief is an innovative radiofrequency treatment that has been approved by the FDA for relieving chronic knee pain due to osteoarthritis. It is minimally invasive, has no scarring, and can provide up to 12 months of relief with no side effects or risk of drug dependence.