Edwards Lifesciences Corporation EW recently announced FDA approval for expanding the use of its flagship SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems to treat severe, symptomatic aortic stenosis (AS) patients who face a low risk of open-heart surgery.
The SAPIEN 3 TAVR’s (transcatheter aortic valve replacement) low-risk approval was based on remarkable outcomes on AS patients, after being treated with the SAPIEN 3 TAVR. Notably, the TAVR with SAPIEN 3 system has been proved to be a preferred line of treatment over surgery.
For investors’ notice, this FDA approval covers the SAPIEN 3 and SAPIEN 3 Ultra valves in all sizes. The approval is expected to enable all patients suffering from severe AS to be considered for treatment on TAVR, according to their individual preferences and anatomical considerations.