CoreValve – BIBA Medtech Insights

Two studies suggest mortality lower with Sapien than with CoreValve

Sapien 3 and CoreValve Evolut Pro According to two studies published in Circulation, the balloon-expandable Sapien (Edwards Lifesciences) transcatheter aortic valve implantation (TAVI) system is associated with lower mortality than is the self-expanding CoreValve (Medtronic) system. These findings have led to calls for randomised head-to-head trials comparing the two devices. In their [...]

FDA approval for Evolut PRO+

Evolut PRO+ The FDA has approved the Evolut PRO+ transcatheter aortic valve implantation (TAVI) system, which a press release states builds off the proven self-expanding, supra-annular Evolut TAVI platform. The press release adds that the Evolut PRO+ includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for [...]