Mainstay Announces Results from ReActiv8-B Study of Back Pain
November 2018 issue
Mainstay Medical International plc, the Dublin, Ireland manufacturer of neuromodulation systems, announced headline from its ReActiv8-B study. The clinical study is a prospective, randomized, active-controlled, blinded trial with one-way cross-over. A total of 204 patients were implanted with ReActiv8 and randomized 1:1 to therapy or control 14 days after implant. In the treatment group, the ReActiv8 pulse generator was programmed to deliver electrical stimulation expected to elicit contractions of the multifidus muscle. In the control group, the ReActiv8 device was programmed to provide a low level of electrical stimulation. Following assessment of the primary endpoint at 120 days, patients in the control group crossed-over to receive levels of electrical stimulation as in the treatment group. In the treatment group the responder rate at 120 days was 56 percent, compared to 47 percent in the control group, resulting in a difference that is not statistically significant.
“Our study involved surgically implanting a device into patients who had not previously received surgical implants, and further required the patient to activate the device twice daily to administer the therapy,” said Jason Hannon, CEO of Mainstay. “The study design underestimated the amount and duration of the sham effect under these conditions. The overall results of this study, however, are a solid endorsement of the efficacy and safety of ReActiv8. We plan to leverage these results in continuing to drive our commercial business under our existing CE Mark in Europe.”
The protocol permitted patients to adjust their back pain medication usage after the 120-day assessment point. At one year, 44 percent of the 50 patients who were on opioids at baseline had voluntarily eliminated or significantly reduced their use of opioids.