All commercial, clinical, R&D and manufacturing activities surrounding the product will end.
Despite pricing pressures, several sectors within the medical device industry can expect to enjoy growth and attract attention from investors.
The approval is for transcatheter aortic valve replacement in severe symptomatic aortic stenosis patients.
The device expands treatment to an additional patient population.
FDA has granted a first-of-its-kind expanded approval for Medtronic’s CoreValve System for valve-in-valve replacement.
The market value for transcatheter heart valves will exceed $3 billion by 2020, and adoption of next-generation valves will drive significant market growth, provided that positive clinical data continues, according to research and consulting firm GlobalData.