Ireland-based medical device company Mainstay Medical has submitted a pre-investigational device exemption (IDE) information package to the US Food and Drug Administration (FDA) for its implantable neurostimulation device ReActiv8 for the treatment of people with chronic low back pain.
The company can request feedback from the FDA on its planned ReActiv8 IDE submission under the pre-IDE submission program of the agency.
Mainstay Medical CEO Peter Crosby said that the pre-IDE submission to the FDA is a significant step on the path to regulatory approval and commercialization of ReActiv8.
"We will consider the FDA’s feedback in our planned IDE submission. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from Chronic Low Back Pain," Crosby added.
Currently, clinical trials are ongoing in Europe and Australia, and several sites have been actively enrolling subjects since March 2014 to investigate ReActiv8 as a treatment for adults with debilitating chronic low back pain who have few other treatment options.