JenaValve, fresh off of a $63 million funding round, said it won CE Mark approval in the European Union for its transapical replacement heart valve to treat aortic insufficiency, also known as aortic regurgitation.
The expanded approval makes JenaValve’s transcatheter aortic replacement valve implant the world’s only such device approved to treat high-risk or inoperable aortic insufficiency, according to a press release.