Nuvectra Corp. submitted a pre-market approval application to the U.S. FDA for Virtis, its sacral nerve stimulation system for the treatment of chronic urinary retention and the symptoms of overactive bladder.
The pre-market approval application, along with a submission to CE Mark authorities, positions the company to release the system in the European market by the end of 2017 and to begin commercialization efforts in the U.S. sometime in 2018, pending timely regulatory approval from each authority.