The Food and Drug Administration (FDA) has granted premarket approval (PMA) for an implantable neurostimulation system (ReActiv8; Mainstay, Dublin, Ireland) to treat intractable chronic low back pain (CLBP).
The FDA approval grants the right to market the neurostimulation system in the US as an aid in the management of intractable CLBP associated with multifidus muscle dysfunction, as evidenced by imaging or physiologic testing in adults whose pain has not responded to pain medications or physical therapy, and are not candidates for spine surgery.
The neurostimulation system is an active implantable medical device designed to treat people with CLBP. The neurostimulation system provides bilateral electric stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. Stimulation of the nerve elicits contraction of the lumbar multifidus, which can lead to improvement in CLBP and its disabling effects.
Jason Hannon, chief executive officer of Mainstay, said: “I am so proud of our team and the dedicated physicians who managed our clinical trials and cared for their patients. We are thrilled to receive FDA approval of the neurostimulation system, which is designed to be a restorative treatment and represents a new option for patients suffering with CLBP. This disease affects millions of people around the world, and our clinical data demonstrates that ReActiv8 therapy provides progressive improvements in pain and disability over time, both in magnitude of effect and the proportion of patients who benefit from the treatment. 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 US 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.”
The FDA approval of the neurostimulation system is based on results from the ReActiv8-B clinical study (NCT02577354), a pivotal international, multicenter prospective randomized active sham-controlled blinded trial in 204 participants with 1-way crossover, conducted under an Investigational Device Exemption (IDE) from the FDA.
Jason A. Ellis, MD; Benjamin W. Y. Lo, MD; Chirag G. Bhatia, BS; Yona Feit; Steven Mandel, MD; and Dana Shani, MD
Jill M. Giordano Farmer, DO
James Geyer, MD, and Paul Cox