FDA Relies On Short-Term Data To Approve Medtronic's Recapturable TAVR System
The approval comes less than a week after FDA approved Edwards' Sapien 3 third-generation transcatheter aortic replacement valve. Both devices were approved based on short-term outcomes data instead of the two-year data FDA has required of TAVR systems in the past.
FDA has approved Medtronic PLC's CoreValve Evolut R transcatheter aortic valve replacement system, the second next-generation TAVR device the agency has approved in the last few weeks based on short-term outcomes data.
