FDA approves implantable device for chronic low back pain
The U.S. Food and Drug Administration has granted pre-market approval for the production of an implantable neurostimulator for chronic low back pain.
According to food and drug administration(FDA) Mainstay Medical Holdings shall be manufacturing the device, called ReActiv8, which will be available in early 2021.
ReActiv8 is an active implantable medical device designed to treat people with chronic low back pain (CLBP). ReActiv8 provides 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,hich can lead to improvement in CLBP and its disabling effects.
New device ReActiv8 is intended for those patients unfit for spine surgery or spinal cord stimulation and who have continuing pain despite medical management.
"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.
The food and drug administration (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 food and drug administration.
"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.
Low back pain is the number one cause of years lived with disability worldwide and a leading cause of activity limitation and work absence throughout much of the world, imposing a high economic burden on individuals, families, communities, industry and governments. While treatment options exist for patients with CLBP of a predominantly neuropathic origin, for the large portion of patients whose pain is predominantly nociceptive (or mechanical) in nature there are few therapies beyond drugs and injections, both of which merely mask the pain. ReActiv8 is intended for those patients without indications for spine surgery or spinal cord stimulation and who have continuing pain despite medical management. The Company currently estimates that there are approximately two million people in the EU and the U.S. who could be candidates for ReActiv8.
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