Sam Brusco, Associate Editor03.19.24
Mainstay Medical has published the five-year follow-up from its ReActiv8-B randomized, sham-controlled, double-blinded trial.
126 patients finished the five-year follow-up, and the company said published data showed that ReActiv8 restorative neurostimulation is a long-term, effective, durable, and safe therapy. ReActiv8 is currently the only restorative therapy for patients suffering from non-surgical, mechanical chronic low back pain (CLBP) related to multifidus dysfunction.
The study observed multiple patients have their implants removed to resolve back pain. The company claimed these removals for success suggest a restorative mechanism, and the therapy shows no evidence of loss of efficacy usually observed with palliative treatments.
Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and who aren’t candidates for spine surgery. ReActiv8 has earned regulatory approval in several geographic areas, and is commercially available in the EU, Australia, the UK, and the U.S.
Dr. Chris Gilligan, chief medical officer and chief quality officer at Robert Wood Johnson University Hospital, said, “The long-term, durable patient outcomes from this study are unprecedented in the field of neuromodulation. This is truly a unique therapy that is restorative in nature and does not show any of the loss of efficacy seen with other treatments in our field. With 5 year published outcomes, we are no longer limited to providing temporary or palliative treatments to our patients. ReActiv8 is changing the way we treat properly selected patients.”
Mainstay Medical CEO Jason Hannon added, "We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population. We look forward to sharing this data with our physician customers and their patients, as well as using it to further engage managed care organizations in the United States to expand commercial insurance access to this incredible therapy.”
126 patients finished the five-year follow-up, and the company said published data showed that ReActiv8 restorative neurostimulation is a long-term, effective, durable, and safe therapy. ReActiv8 is currently the only restorative therapy for patients suffering from non-surgical, mechanical chronic low back pain (CLBP) related to multifidus dysfunction.
The study observed multiple patients have their implants removed to resolve back pain. The company claimed these removals for success suggest a restorative mechanism, and the therapy shows no evidence of loss of efficacy usually observed with palliative treatments.
Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and who aren’t candidates for spine surgery. ReActiv8 has earned regulatory approval in several geographic areas, and is commercially available in the EU, Australia, the UK, and the U.S.
Dr. Chris Gilligan, chief medical officer and chief quality officer at Robert Wood Johnson University Hospital, said, “The long-term, durable patient outcomes from this study are unprecedented in the field of neuromodulation. This is truly a unique therapy that is restorative in nature and does not show any of the loss of efficacy seen with other treatments in our field. With 5 year published outcomes, we are no longer limited to providing temporary or palliative treatments to our patients. ReActiv8 is changing the way we treat properly selected patients.”
Mainstay Medical CEO Jason Hannon added, "We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population. We look forward to sharing this data with our physician customers and their patients, as well as using it to further engage managed care organizations in the United States to expand commercial insurance access to this incredible therapy.”