FDA OKs Implantable Neurostimulator for Intractable Low Back Pain

Megan Brooks

June 22, 2020

The US Food and Drug Administration (FDA) has approved an implantable neurostimulation system (ReActiv8, Mainstay Medical) to treat intractable chronic low back pain associated with multifidus muscle dysfunction found on imaging or physiologic testing in adults who have failed other therapies and are not candidates for spine surgery.

"ReActiv8 provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. This nerve supplies the lumbar multifidus muscle, a key stabilizing muscle of the low back. Reactiv8's stimulation of the nerve elicits contraction of the muscle, which can lead to improvement in chronic low back pain and its disabling effects," Mainstay Medical said in a release.

The FDA approved ReActiv8 based on results the international ReActiv8-B investigational device exemption (IDE) study. A total of 204 patients participated in prospective, randomized, active sham-controlled, blinded trial with one-way crossover.

The results indicate 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," the company said.

"I have seen ReActiv8 provide durable improvements in back pain, the disabling effects of back pain, and quality of life," Chris Gilligan, MD, chief, Division of Pain Medicine, Brigham & Women's Hospital, Boston, Massachusetts, and principal investigator of the ReActiv8-B study, said in the release.

Also commenting in the release, Robert Levy, MD, PhD, president, International Neuromodulation Society (INS), said ReActiv8 "represents a new treatment category for this severely affected patient population. The use of neuromodulation to target underlying functional and motor-control issues in patients with musculoskeletal back pain can address a large unmet clinical need."

Levy noted that ReActiv8 is designed as a restorative therapy and does not compete with other forms of neuromodulation such as spinal cord stimulation.

"These patients are difficult for clinicians to treat with current therapy options, which is why so many of them take opioids to manage their pain. Having been part of the neuromodulation field for so long, I am really impressed by this particular innovation and I look forward to its adoption in clinical practice," said Levy.

Mainstay Medical expects to begin marketing ReActiv8 in first half of 2021.

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