Mainstay Medical Holdings recently announced the commercial launch in Australia of ReActiv8®, its implantable neurostimulation system to treat chronic low back pain.
“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,” said Jason Hannon, CEO of Mainstay.
The first commercial ReActiv8 implant in Australia was conducted by Associate Professor Bruce Mitchell, Sports and Interventional Pain Physician and Director of Metro Pain Group in Melbourne, Australia.
“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,” said Associate Professor Bruce Mitchell.
ReActiv8 is an active implantable medical device designed to treat adults with intractable chronic low back pain associated with dysfunction of the lumbar multifidus muscle, a key stabilising muscle of the low back, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery. ReActiv8 provides 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 CLBP.
The ReActiv8 Restorative Neurostimulation therapy has a CE Mark allowing for commercialization in the European Economic Area and has been focused on