Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, announced that the U.S. Food and Drug Administration (FDA) conditionally approved the first of two planned cohorts of the randomized, controlled The PARTNER II Trial. Building upon the learnings of the world's first randomized transcatheter heart valve trial -- Edwards' The PARTNER Trial -- the first cohort of The PARTNER II Trial will study the next-generation Edwards SAPIEN XT transcatheter heart valve. This trial includes the low-profile NovaFlex transfemoral delivery system, which broadens the number of eligible patients.

This cohort of The PARTNER II Trial will study up to 450 patients with severe, symptomatic aortic stenosis using two-to-one randomization, where for every two patients who receive the Edwards SAPIEN XT valve delivered transfemorally, one will receive standard therapy. The primary endpoint of the trial is a composite of death, major stroke and repeat hospitalization, with secondary endpoints that include valve performance and quality-of-life indicators.

Edwards anticipates a second patient cohort for the trial to compare traditional open-heart surgery with the Edwards SAPIEN XT valve delivered either transfemorally or transapically.

The Edwards SAPIEN XT valve is commercially available in Europe, where it received a CE Mark in March 2010. The Edwards SAPIEN XT transcatheter valve is an investigational device in the U.S. and not yet available commercially in this country.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at www.edwards.com.