Mainstay Medical announced that it received FDA premarket approval for its ReActiv8 implantable neurostimulation system for chronic low back pain.
ReActiv8 treats intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy and are not candidates for spine surgery, according to a news release.
Mainstay said ReActiv8 garnered PMA after a 204-patient, international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way crossover that was conducted under FDA investigational device exemption.
The company said it is now refining its U.S. commercial launch plans for ReActiv8, including the build-out of its commercial team, inventory procurement and related matters, along with evaluating the needed financial resources.
“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.