IRVINE, CA, Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, 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're pleased we can now help even more patients in need," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement.

The Edwards SAPIEN XT 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, and is an investigational device in the United States that is being studied in The PARTNER II Trial, a randomized controlled study.

Source: Edwards Lifesciences Corporation