Edwards' Sapien TAVI device closer to US approval with positive FDA report
This article was originally published in Clinica
Executive Summary
Edwards Lifesciences looks ever closer to achieving its goal of launching its Sapien heart valve system in the US this year, after FDA reviewers issued a positive report on the safety and efficacy data of the device. The report should work in Edwards' favour tomorrow (20 July) when Sapien comes under scrutiny by the agency's advisory panel – a recommendation by the panel could help the firm clinch final premarket approval for Sapien, making it the first transcatheter aortic valve implantation (TAVI) system to hit the US.