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Mainstay Medical Submits CE Mark Application for ReActiv8

November 2, 2015

As a next step to EU commercialization, medical devicemaker Mainstay Medical International has submitted an application for a CE Mark for its ReActiv8 system.

ReActiv8 is an implantable neurostimulation system intended to treat disabling chronic low back pain. It works by stimulating the nerves responsible for contracting the muscles that stabilize the lower back.

The application includes the results of a clinical trial that showed lasting improvement in pain, disability and quality of life for people with chronic low back pain and limited treatment options, according to the company.

Mainstay is planning to establish a direct sales force for commercialization in key European markets starting in 2016. — Michael Cipriano