New data on Mainstay Medical’s flagship medical device for treating chronic low back pain has further established its safety and efficacy, showing the device is maintaining its effectiveness long term.
The data, which was published in the journal of the International Neuromodulation Society, Neuromodulation, looked at three-year outcomes for patients on its ReActiv8 device clinical trial.
“The recently published data from the ReActiv8-B clinical trial continued to show clinically meaningful improvements in both pain and function for patients with refractory chronic low back pain who received three years of neurostimulation,” said Chris Gilligan, principal investigator of the study. “The long-term trajectory and durability of clinical benefits are consistent with the restoration of neuromuscular control and muscle rehabilitation, which gives us confidence that we are able to treat the underlying cause of chronic low back pain in these patients.”
ReActiv8, which won European approval in 2016, is implanted in a surgical procedure and works by electrically stimulating nerves in muscles supporting the lower spine. It made its first commercial sale for ReActive8 in 2017 shortly after it won a CE mark, which authorises the product’s sale across the EU.
“These three-year results further validate ReActiv8′s restorative mechanism of action, which treats a primary underlying cause of mechanical chronic lower back pain, multifidus dysfunction. 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, and we look forward to continuing to generate clinical and other research to compel physicians and their patients to further utilise the therapy.”
The company estimates that there are about 2 million people in the EU and the US who could be candidates for ReActiv8. It estimates the market for disabling chronic lower back pain in patients not suitable for surgery is worth approximately $30 billion (€? billion).