ReActiv8, an implantable neurostimulation system designed to treat chronic low back pain that cannot be fixed by surgery or other treatment options, has received FDA approval. The device is specifically designed to treat back pain caused by delivering electrical stimulation to the multifidus muscle. The multifidus muscle is used in stabilizing the spine, so in patients with dysfunction in this muscle, the stimulation strengthens the multifidus muscle through stimulation allows greater stability and reduced pain in the spine. The device is designed for patients who are not good surgical candidates but want to avoid drugs and injections which mask the pain but don’t address the underlying problem.
Mainstay Medical, the Irish company behind ReActiv8 may now market the device in the US. The approval is based primarily on the results of a 204 patient survey performed at a variety of locations internationally. Study details can be found here though the efficacy results do not seem to have been made available as of yet.
Mainstay estimates there are 2 million candidates in the US and EU, a relatively modest number given that an estimated 16 million people experience chronic low back pain each year in the US alone.
The device is expected to hit the US market in early 2021. In Europe the system is approved for commercialization but is undergoing further clinical validation in a small number of German centers, before being available to the European market more broadly. In Australia, the device is eligible for reimbursement by insurance starting July 1, 2020.
The original press release from Mainstay can be found here.