According to a press release, Mainstay Medical has submitted a CE mark application for its ReActiv8 implantable neurostimulation device, designed to treat disabling chronic low back pain for whom conventional therapy has not been successful and for whom surgery is not indicated.
Mainstay’s application for CE mark follows the results of the ReActiv8-A clinical trial which showed clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life for people with chronic low back pain and limited treatment options.
Peter Crosby, chief executive officer of Mainstay, says, “The application for CE mark approval is a significant milestone for Mainstay and follows the successful results of our ReActiv8-A trial. With FDA approval to start the ReActiv8-B clinical trial to gather data for an application for US approval, we are moving towards our goal of commercialisation of ReActiv8 in major world markets. We are now a step closer to selling ReActiv8 in Europe.”
ReActiv8-A is an international, multi-centre, prospective single arm clinical trial that recruited subjects who were not candidates indicated for surgery or spinal cord stimulation, and who had attempted other therapies, including at least physical therapy.
Data have been reported for the first 46 subjects in the ReActiv8-A trial. After 90 days of treatment with ReActiv8, 63% of people showed a clinically important improvement in their low back pain, 57% showed a clinically important improvement in their disability and 67% showed a clinically important improvement in their quality of life. Improvements in low back pain, disability and quality of life were generally consistent or improved at 180 days.