July 11, 2020
1 min read

FDA approves implantable neurostimulation system for chronic low back pain

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The FDA has approved Mainstay Medical’s premarket approval application for ReActiv8, an implantable neurostimulation system for the management of intractable chronic low back pain, according to a company press release.

ReActiv8, which can now be marketed in the United States, is intended for adult patients with multifidus muscle dysfunction who have failed therapy and are not candidates for spine surgery, according to the release. The device is designed to stimulate the nerve that elicits contraction of the lumbar multifidus muscle, leading to the improvement of chronic low back pain.

“I am so proud of our team and the dedicated physicians who managed our clinical trials and cared for their patients. We are thrilled to receive FDA approval of ReActiv8, which is designed to be a restorative treatment and represents a new option for patients suffering with chronic low back pain,” Mainstay CEO Jason Hannon said in the release. “This disease affects millions of people around the world, and our clinical data demonstrates that ReActiv8 therapy provides progressive improvements in pain and disability over time, both in magnitude of effect and the proportion of patients who benefit from the treatment. This therapy has the potential to improve quality of life for the most severely affected patients, and we look forward to making it available to U.S. patients and physicians beginning in the first half of 2021,” he added.