Mainstay Medical Holdings plc, based in Dublin, Ireland, has announced the limited U.S. commercial launch of ReActiv8, its implantable restorative neurostimulation system meant for the treatment of intractable chronic low back pain associated with dysfunction of the lumbar multifidus muscle, a stabilizing muscle of the low back.
Novel Treatment for Chronic Low Back Pain Launched in U.S.
1 min read Premium comments
Secondary#neurostimulation#mainstaymedical#reactiv8
According to the company, ReActiv8 works by providing “bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. Stimulation of this nerve that supplies the multifidus muscle elicits contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from chronic low back pain.”
Mainstay Medical CEO Jason Hannon told OTW, “ReActiv8 is the product of more than 10 years of research that helps us understand the patients most likely to benefit. The therapeutic options for these patients are currently limited, so most of them cycle through temporary treatments like medications, physical therapy, injections and opioids.”
“With the launch of ReActiv8 we are providing tools to assist physicians in identifying and caring for the appropriate patients. These include: a step-by-step guide to patient selection, multiple publications (including real world evidence) showing clinical results, a new website centered on patient education, a program that helps connect patients with physicians trained on ReActiv8, and a multi-part physician education program that provides detailed training to physicians on the therapy.”
When OTW asked how ReActiv8 relieves chronic back pain, Hannon explained, “Rather than utilizing traditional neurostimulation methods that seek to mask pain sensation, ReActiv8 is designed to target a key source of low back pain and thereby be restorative.”
Furthermore, said Hannon, “The programs we are launching alongside ReActiv8 are dedicated to educating physicians on which patients have proven to respond most significantly and how to care for those patients. In addition, we have gathered long-term as well as real world clinical data on the use of the therapy which we believe will greatly help physicians choose the appropriate patients.”
Patients and physicians can find additional information at Mainstay’s new corporate website.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.