ReActiv8 treats intractable chronic low back pain related to dysfunction of lumbar multifidus muscle, in adults who are not eligible for spine surgery
Mainstay Medical has announced the commercial launch of its implantable neurostimulation system ReActiv8 in Australia to treat chronic low back pain (CLBP).
ReActiv8 is designed to treat adults with intractable chronic low back pain related to dysfunction of lumbar multifidus muscle, who are not eligible for spine surgery.
Lumbar multifidus is a muscle that plays important role in stabilising low back, as determined by imaging and physiological testing.
The first commercial use of ReActiv8 was conducted in Australia at the Metro Pain Group by sports and interventional pain physician Bruce Mitchell.
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.”
The neurostimulation system provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve, as it crosses the transverse process at L3.
Stimulation of the nerve elicits contraction of the muscle which can lead to the restoration of control over time, allowing the back to recover from CLBP, said the company.
The restorative neurostimulation therapy using ReActiv8 has been granted a CE Mark, allowing its marketing in Europe.
The company has secured the US Food and Drug Administration (FDA) approval for the system in June 2020, with plans to launch in the US, in early 2021.
Mainstay Medical said that it has been working on building clinical validation of the system in select centres across Germany, prior to wider commercial availability.
Also, ReActiv8 has been registered in the Australian Register of Therapeutic Goods (ARTG), for commercialisation across Australia.
Mainstay 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.
“We are excited to make ReActiv8 commercially available to Australian physicians and their patients suffering from mechanical chronic low back pain.”