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The U.S. Food and Drug Administration has granted pre-market approval to Mainstay Medical Holdings for the production of an implantable neurostimulator for chronic low back pain.
The device, called ReActiv8, should hit the U.S. market in early 2021.
"This therapy has the potential to improve quality of life for the most severely-affected patients, and we look forward to making it available to U.S. patients and physicians beginning in the first half of 2021. This will build upon our growing business in Europe and our upcoming launch in Australia," said Jason Hanson, Mainstay CEO. The device has been approved in Australia and for the European Union, the company said in a statement.
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. This nerve supplies the lumbar multifidus muscle, a key stabilizing muscle of the low back. Reactiv8’s stimulation of the nerve elicits contraction of the muscle, which can lead to improvement in CLBP and its disabling effects.
The FDA approval of ReActiv8 is primarily based on results from the ReActiv8-B clinical study, a pivotal 204-patient, international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from FDA.
"While treatment options exist for patients with chronic low back pain of a predominantly neuropathic origin, for the large portion of patients whose pain is predominantly nociceptive (or mechanical), there are few therapies beyond drugs and injections, both of which merely mask the pain," the company said in a statement.
ReActiv8 is intended for those patients without indications for spine surgery or spinal cord stimulation and who have continuing pain despite medical management.