Mainstay Appeals to FDA for IDE

Irish company Mainstay Medical International plc has submitted a pre-investigational device exemption (IDE) information package to the U.S. Food and Drug Administration (FDA) for ReActiv8, its implantable neurostimulation device for the treatment of chronic low back pain.

Under the FDA’s pre-IDE submission program, Mainstay can request feedback from the agency on its planned ReActiv8 IDE submission. The FDA states that “Receiving and incorporating FDA feedback on various elements of a future IDE submission, such as the proposed study design or statistical analysis plan, can facilitate the IDE review process and reduce the number of review cycles needed to reach full IDE approval.”

“The pre-IDE submission to the FDA is a significant step on the path to regulatory approval and commercialization of ReActiv8,” said CEO Peter Crosby. “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.”

Clinical trials with ReActiv8 are ongoing in Europe and Australia, and several sites have been actively enrolling subjects since March 2014. The purpose of the trial is to investigate ReActiv8 as a treatment for adults with debilitating chronic low back pain who have few other treatment options.

Mainstay recently expanded its ReActiv8 trials into Belgium and Australia.