ReActiv8 Neurostimulator Treats Cause of Back Pain, Now FDA Approved


Mainstay Medical, an Irish firm, just won FDA approval to introduce its ReActiv8 neurostimulator that works to address the underlying causes of back pain. Most existing pain reducing implants work to simply mask the pain by delivering electrical signals to the relevant nerves. The ReActiv8 instead stimulates the multifidus muscle, that lies next to the spine and helps to stabilize nearby joints, the control of which is often lost because of injury or disease. By helping to “reactivate” this muscle, the approach leads to strengthening of the muscle, support for the spine, and a reduction in pain.

Therapy can be delivered at home by patients themselves, who can activate the neurostimulation and control its intensity. Over time the multifidus muscle strengthens and the closed-loop of injury causing muscle weakness and further injury is broken.

“ReActiv8 fills an important unmet clinical need of patients suffering from chronic low back pain,” said Dr. Chris Gilligan, Chief, Division of Pain Medicine, Department of Anaesthesiology, Perioperative and Pain Medicine, Brigham & Women’s Hospital, Assistant Professor of Anaesthesia, Harvard Medical and Principal Investigator of the pivotal ReActiv8-B study, in a press release. “Patients indicated for ReActiv8 therapy have generally tried numerous other treatments, including physical therapy and pain medications, and many are on long-term opioids to manage their pain. I have seen ReActiv8 provide durable improvements in back pain, the disabling effects of back pain, and quality of life. I am proud to have served as Principal Investigator of this landmark trial, and I look forward to sharing this experience with my physician colleagues who want to start using ReActiv8 in their patients.”

Here’s a quick intro video explaining how the ReActiv8 works:

Product page: ReActiv8…

Flashback: ReActiv8 Implantable Muscle Stimulator for Treating Chronic Lower Back Pain EU Cleared

Via: Mainstay Medical

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