Mainstay Medical reaches next stage of US approval process
FDA has accepted filing for pre-market approval application
Medical device company Mainstay Medical said the process of bringing its implantable neurostimulation system for chronic bank pain sufferers to the US has reached the next stage, with the Food and Drug Administration (FDA) accepting its filing for pre-market approval application.
The filing was submitted in August for ReActiv8, following a series of meetings with the US regulator, with the FDA due to respond within 45 days of submission. The company said it expects a decision on approval around the end of 2020.
While Mainstay failed to meet the primary endpoints in the Reactiv8 B trial, further analysis of the data has given the company confidence in its prospects for approval to enter the US market.
The company is also continuing to expand its service in Germany, its main European market, and has also completed its first implant in Switzerland and the first couple in the UK where the priority over the next six months is to ensure they get reimbursed.