Mainstay Medical files Pre-IDE information package to FDA for ReActiv8

7 July 2014 (Last Updated July 7th, 2014 18:30)

Ireland-based Mainstay Medical has submitted a pre-investigational device exemption (IDE) information package to the US Food and Drug Administration (FDA) for its implantable neurostimulation solution ReActiv8 to treat people with chronic low back pain (CLBP).

Ireland-based Mainstay Medical has submitted a pre-investigational device exemption (IDE) information package to the US Food and Drug Administration (FDA) for its implantable neurostimulation solution ReActiv8 to treat people with chronic low back pain (CLBP).

As part of the Pre-IDE Submission Programme, the company can request feedback from the FDA on its planned ReActiv8 IDE submission.

"Receiving and incorporating FDA feedback on various elements of a future IDE submission can facilitate the IDE review process and reduce the number of review cycles needed to reach full IDE approval."

The FDA said: "'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."

Mainstay Medical CEO Peter Crosby said: "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 are currently being carried out in Europe and Australia, and several sites have been actively enrolling subjects since March 2014 to assess ReActiv8 as a treatment for adults with debilitating chronic low back pain who have few other treatment options.

Mainstay is focused on developing new implantable neurostimulation medical device, ReActiv8, for people with debilitating CLBP, which is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.