Sapien XT Transcatheter Valve Offers Smaller Profile

Approval includes high-risk and inoperable indications, transfemoral and alternative access systems


June 18, 2014
Sapien XT, FDA

The Edwards Sapien XT transcatheter aortic heart valve is indicated for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS). This next-generation, lower-profile system, which includes the 29 mm valve size for patients with a large native annulus, will allow for the treatment of more patients. 

The balloon-expandable valve will be immediately available to patients at leading cardiovascular centers across the nation, along with the NovaFlex+ transfemoral delivery system that can be delivered through a low-profile 16-French expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery systems. 
 The Sapien XT is a revised version of their earlier Sapien transcatheter heart valve. It uses a smaller profile delivery system that enables use in patients with smaller or severely diseased vessels. The Sapien XT is also available with an additional, larger size 29 mm valve. The U.S. Food and Drug Administration (FDA) cleared the XT in June 2014. For more information: