The US Food and Drug Administration (FDA) has approved the Mainstay Medical’s Premarket Approval (PMA) application for ReActiv8, an implantable neurostimulation system to treat intractable chronic low back pain (CLBP).
The system provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. The nerve supplies the lumbar multifidus muscle, a key stabilising muscle of the low back.
The stimulation provided by ReActiv8 induces muscle contraction, which can lead to an improvement in CLBP and its effects.
The regulatory approval allows the company to commercially launch ReActiv8 in the US for the management of intractable chronic low back pain associated with multifidus muscle dysfunction.
It is designed for patients who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery.
The system was granted approval based on results from the ReActiv8-B clinical study conducted under an Investigational Device Exemption (IDE) from the FDA.
Following the FDA approval, Mainstay is preparing for the commercial launch of ReActiv8 system in the US.
Mainstay CEO Jason Hannon said: “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 the magnitude of the effect and the proportion of patients who benefit from the treatment.
“This therapy has the potential to improve the 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.”