Mainstay Medical’s Chronic Low Back Pain Device Approved

The FDA has approved Mainstay Medical’s premarket approval application for Reactiv8, an implantable neurostimulation system designed to treat chronic low back pain.

The approval allows the product to be marketed in the U.S. for management of intractable chronic low back pain associated with muscle dysfunction in adults who have failed other therapy and cannot undergo spinal surgery.

The company plans to launch the product in the first half of 2021.