FDA approves first TAVR platform to treat severe asymptomatic aortic stenosis

Edwards Lifesciences announced the FDA approved its transcatheter aortic valve replacement platform for treatment of severe asymptomatic aortic stenosis, the first in this patient population.Approval of this platform (SAPIEN 3, SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA) was based on the results of the EARLY TAVR trial which were presented at TCT 2024 and simultaneously published in The New EnglandRead More