Edwards receives CE mark approval for a larger version of its Sapien XT transcatheter aortic valve

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Edwards Lifesciences has announced that it has received CE mark for the 29 millimeter version of its Edwards Sapien XT transcatheter aortic heart valve.

The valve will be available with the Ascendra transapical delivery system for implantation through a small incision between the ribs, and this new offering increases the valve portfolio to three sizes.

 

“We knew it was important to provide patients with a 29 millimeter valve, and we are pleased we can now help even more patients in need,” said Larry L. Wood, Edwards’ corporate vice president, Transcatheter Valve Replacement.

 

This valve builds upon the innovative features of the Edwards Sapien valve, incorporating a tissue leaflet design that is modeled on Edwards’ surgical aortic tissue valves, which have clinically proven durability, and a cobalt chromium frame that provides improved radial strength.

 

The Edwards Sapien XT valve has been used widely by clinicians throughout Europe since its commercial launch in the region in 2010.  In the United States, the Edwards Sapien XT valve is not yet commercially available; it is under investigation, being studied as part of the PARTNER II trial (Placement of aortic transcatheter valves), the world’s first randomised, pivotal clinical trial of a transcatheter aortic valve in patients with calcific aortic stenosis who are considered high-risk for conventional open-heart valve surgery.