Edwards' PARTNER Study Enrollment Marks Milestone

March 17, 2009—Edwards Lifesciences LLC (Irvine, CA) announced the completion of enrollment in the 350-patient nonsurgical study arm of the US pivotal PARTNER (Placement of Aortic Transcatheter Valves) trial for the Edwards Sapien transcatheter aortic heart valve. The PARTNER trial is a randomized, controlled, multicenter study that assigns patients to one of two arms: a nonsurgical arm, in which the Edwards Sapien valve is compared to nonsurgical treatments, and a surgical arm, in which the Edwards Sapien valve is compared to traditional surgical aortic valve replacement. Craig Smith, MD, and Martin B. Leon, MD, are the principle investigators of the PARTNER trial.

The company also announced that it plans to provide continued access at PARTNER study sites to the Edwards Sapien valve for nonsurgical patients meeting study criteria, pending approval of the Food and Drug Administration.