TGA Approves Mainstay Medical’s Implantable Neurostimulator

Australia’s Therapeutic Goods Administration (TGA) granted approval to Mainstay Medical for its ReActiv8 device, an implantable neurostimulator that treats chronic low back pain.

The device electrically stimulates nerves in the lumbar multifidus muscle, one of the lower back’s main stabilizing muscles, making it contract in order to restore control over time.

The devicemaker is applying for the product’s inclusion on the prostheses list of devices covered by private health insurers and plans to launch the product following its addition.