Edwards Receives Approval to Begin U.S. Clinical Trial (EW)

Edwards Lifesciences Corporation

earlier today 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.