Mainstay Medical has commercially launched its implantable neurostimulation system, ReActiv8, for treating chronic low back pain (CLBP) in Australia.
The device can potentially treat adults with intractable CLBP linked to the dysfunctioning of a key stabilising muscle of the low back, the lumbar multifidus muscle.
It was evidenced by imaging or physiological testing in adults with failed therapy such as pain medications and physical therapy who are not spine surgery candidates.
ReActiv8 offers bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3.
Stimulating the nerve, which supplies the multifidus muscle, it elicits muscle contraction that can induce restoration of control over time, helping the back to recover from CLBP.
A major cause of CLBP is the nervous system’s impaired control of the muscles, which stabilise the spine. By electrically stimulating the nerves responsible for contracting the muscles, ReActiv8 could enhance dynamic spine stability.
Mainstay Medical CEO Jason Hannon said: “Launching ReActiv8, our Restorative Neurostimulation therapy, commercially in Australia is a significant milestone for our global commercial expansion.
“Several top Australian physicians have been part of our clinical studies since inception and are among the most experienced globally in selecting and treating patients with ReActiv8.”
The CE-marked ReActiv8 Restorative Neurostimulation therapy is focused on creating clinical validation in Germany in select centres before widespread commercial availability.
Metro Pain Group, Australia director and sports and interventional pain physician Bruce Mitchell said: “Having been involved in both the ReActiv8-A and B Clinical Trials, I am excited to be able to expand this restorative therapy to other patients in my practice.
“The launch in Australia is a great milestone for ReActiv8, and ultimately, the patients that suffer from chronic mechanical low back pain who now have a new treatment option.”