The US Food and Drug Administration (FDA) has cleared the iovera device, from Myoscience, Inc, for the relief of pain and symptoms associated with knee osteoarthritis (OA) for up to 90 days. Myoscience is located in Fremont, California.
"The iovera technology is a nonopioid and nonsystemic treatment for blocking pain signals from peripheral nerves," the company said in a news release announcing FDA 51(k) clearance of the device.
The device uses the body's natural response to cold to treat peripheral nerves. It consists of a hand piece equipped with a nitrous oxide cartridge and three closely spaced 27-gauge closed-end needle tips. The nitrous oxide flows from the cartridge to the needle tips, creating a highly localized cold zone. The effect is transient and provides pain relief until the nerve regenerates and its sensory function is restored.
"The iovera technology has the potential to change the current paradigm of pain management for osteoarthritis. The patients that I have treated with this technology have experienced immediate and long-lasting pain relief and are grateful to have an option that is nonnarcotic and nonsystemic," Vinod Dasa, MD, member of the Myoscience medical advisory board, said in the release.
The FDA cleared the device on the basis of results of a prospective, multicenter, sham-controlled, randomized, double-blind study involving 180 patients. Participants met the American College of Rheumatology clinical and radiographic criteria for knee OA and were ambulatory without assistive devices.
In the study, patients who used the iovera device reported a statistically significant greater reduction in pain and improvement in symptoms (P = .001) when compared to patients who received the sham treatment. With iovera treatment, pain relief lasted up to 90 days and was accompanied by reduced stiffness and improved physical function.
The full study results were published online March 21 in the journal Osteoarthritis and Cartilage and were reported by Medscape Medical News.
"The addition of osteoarthritis to the indications for the iovera treatment will help in extending our innovative nonopioid therapy to more patients, especially in the growing baby-boomer population. I anticipate this technology to become the nonnarcotic and nonsystemic solution of choice to manage knee pain," Cary Vance, Myoscience president and CEO, said in the release.
The iovera cold treatment device has been commercially available in the United States since March 2014. It is indicated for use in pain management and general surgical use, according to the company.
Cite this: FDA Clears Iovera Cold Treatment Device for Knee OA Pain - Medscape - May 18, 2017.