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Mainstay Medical submits Pre-IDE for ReActiv8

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Mainstay Medical International announced it has submitted a pre-investigation device exemption information package to the U.S. Food and Drug Administration for ReActive8, an implantable neurostimulation device designed to treat chronic back pain.

With the pre-IDE submission, Mainstay can request feedback from the agency on its planned ReActiv8 submission. The FDA allows for these pre-submissions to simplify the IDE review process and reduce the number of review cycles to achieve IDE approval, according to a Mainstay Medical release.

Clinical trials for ReActiv8 are currently underway in Europe and Australia. Sites have been actively enrolling participants since March to investigate the device’s efficacy.