Mainstay Announces FDA Approval of ReActiv8 Pain Stimulator

June 2020 issue

Mainstay Medical, the Dublin, Ireland manufacturer of neuromodulation systems, announced FDA approval of ReActiv8, its implantable restorative neurostimulation system for chronic low back pain. The FDA approval grants Mainstay the right to market ReActiv8 in the U.S. as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery.

The approval of ReActiv8 is based on results from the ReActiv8-B clinical study, a pivotal sham-controlled clinical trial that failed to meet its primary endpoint in 2018, largely because of a greater than expected sham response [NBR Nov18 p5]. In an interview with NBR, Mainstay CEO Jason Hannon said their approval may be a positive signal for other neuromodulation vendors. “The FDA is trying to increase the rigor of clinical data in this area,” he said. “They’re not doing it with blind adherence to some statistical standard. That should give people optimism. We don’t have a blind regulator that’s simply looking at a p value.”

Hannon admitted to some initial uncertainty about getting approval after the trial failure, but said the FDA was moved by the steady improvement in response as time went on. “The FDA took a good look at our data and did what we asked them to do—look at the totality of the data.

Mainstay is refining its commercial launch plans for ReActiv8 in the U.S., including the build out of the commercial team, inventory procurement and related matters, as well as evaluating the financial resources necessary to fund its planned activities. They plan to be on the market in the U.S. in the first half of next year.