FDA Approves Neurostimulation System for Chronic Low Back Pain

The US Food and Drug Administration (FDA) has approved ReActiv8®, an implantable neurostimulation system designed for the treatment of intractable chronic low back pain associated with multifidus muscle dysfunction.

“ReActiv8 fills an important unmet clinical need of patients suffering from chronic low back pain,” said Chris Gilligan, MD, principal investigator of the ReActiv-8-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,” he added.

The approval was granted based largely on the results of the ReActiv8-B clinical trial (N = 204), which was an international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way cross-over. The trial was performed under an Investigational Device Exemption granted by the FDA.

—Christina Vogt

Reference:
Mainstay Medical announces U.S. FDA approval of ReActiv8® neurostimulation system for chronic low back pain. News release. Mainstay Medical Holdings plc. June 22, 2020. Accessed June 23, 2020. http://www.mainstay-medical.com/sites/default/files/2020-06/Mainstay%20-%20release%20re%20FDA%20approval_0.pdf