Mainstay Medical has announced the publication of the five-year follow-up from its ReActiv8-B randomised, sham-controlled, double-blinded trial in Neuromodulation: Technology at the Neural Interface.
There were 126 patients who completed the five-year follow-up and—as per a Mainstay press release—the published data “clearly indicate” that ReActiv8 restorative neurostimulation is a long-term, effective, durable and safe therapy.
The ReActiv8-B study saw multiple patients have their implants removed due to resolution of back pain. These removals following treatment success suggest a restorative mechanism, the company states, and its therapy shows “no evidence of the loss of efficacy commonly observed with palliative treatments”.
Among key findings detailed in the paper are improvements from baseline regarding visual analogue score (VAS), Oswestry disability index (ODI), and healthcare-related quality of life on the EQ-5D-5L index, associated with ReActiv8 restorative neurostimulation.
“The long-term, durable patient outcomes from this study are unprecedented in the field of neuromodulation,” said Chris Gilligan (Robert Wood Johnson University Hospital, New Brunswick, USA). “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 five-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.”
“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,” added Jason Hannon, chief executive officer of Mainstay. “We look forward to sharing these data with our physician customers and their patients, as well as using them to further engage managed care organisations in the USA to expand commercial insurance access to this incredible therapy.”
Mainstay claims that ReActiv8 is the only restorative therapy for patients suffering from non-surgical, mechanical chronic low-back pain (CLBP) evidenced by multifidus dysfunction.
