Mainstay Medical Submits Pre-IDE Info Package to the FDA for ReActive8
Dublin, Ireland, devicemaker Mainstay Medical said Monday that it has submitted a pre-investigational device exemption information package to the FDA for ReActiv8, an implantable neurostimulator meant to treat people with chronic low back pain.
According to the FDA’s Pre-IDE Submission Program, companies can request input from the agency on planned IDE submissions.
ReActiv8 works by stimulating the nerves responsible for contracting the key muscles that stabilize the lower back. The device is designed to be used twice a day for about 30 minutes a session. Patients control the session with a wireless, handheld remote.
Over time, the stimulated contractions may help a patient’s brain and body learn to better control the muscles between sessions, the company says.
Low back pain is the leading cause of restricted activity and work absenteeism in much of the developed world, Mainstay says, and one of the main causes of pain is impaired control by the nervous system of the spine-stabilizing muscles in the lower back.
Clinical trials of ReActiv8 as a treatment for adults with debilitating chronic lower back pain who have few other treatment options are underway in Europe and Australia. — Kellen Owings
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