Sapien 3 Edwards Lifesciences has received the CE mark for its Sapien 3 transcatheter aortic valve implantation (TAVI) device to be used to manage aortic stenosis in low-risk patients. Both Edwards and Medtronic (with its CoreValve Evolut range) have FDA approval for their devices to be used for low-risk patients in the [...]
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 [...]
The FDA has approved Evolut R, Evolut PRO (Medtronic), Sapien 3 and Sapien 3 (Edwards Lifesciences) for the management of low-risk patients with severe aortic stenosis. The approval follows the publication—in the New England Journal of Medicine—of two studies that showed positive results with these devices in low-risk patients. Prior to the FDA approval, [...]