Edwards Lifesciences Corporation, the world leader in the science of heart valves, today announced completion of enrollment in the 350-patient non-surgical study arm of its U.S. pivotal trial — known as the PARTNER Trial — for the Edwards SAPIEN transcatheter aortic heart valve.
“Reaching this milestone is a significant achievement for the subset of patients suffering from severe aortic stenosis who can’t tolerate conventional aortic valve replacement. Without a transcatheter heart valve, they have no definitive treatment options for addressing their valve disease,” said Craig Smith, M.D., interim surgeon-in-chief and chief of cardiothoracic surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center, the Calvin F. Barber Professor of Surgery at Columbia University College of Physicians and Surgeons, and co-principal investigator for the trial.
The PARTNER (Placement of AoRTic traNscathetER valves) Trial is a randomized, controlled, multi-center study that assigns patients into one of two arms: a “non-surgical” arm, in which the Edwards SAPIEN valve is compared to non-surgical treatments, and a “surgical” arm, in which the Edwards SAPIEN valve is compared to traditional surgical aortic valve replacement.
The company also announced it plans to provide continued access at PARTNER study sites to the Edwards SAPIEN valve for non-surgical patients meeting study criteria, pending FDA approval.
“The dedication of the PARTNER sites in screening and randomizing complex patients is an important achievement. The medical community anxiously awaits results from this landmark trial, which I believe will benchmark the performance of the Edwards SAPIEN valve versus medical management therapies in these high risk patients,” said Martin B. Leon, M.D., associate director of the Cardiovascular Interventional Therapy (CIVT) Program at NewYork-Presbyterian Hospital and Columbia University Medical Center, professor of medicine at Columbia University College of Physicians and Surgeons, and co-principal investigator for the U.S. PARTNER Trial.
Edwards is the only company with a U.S. investigational device exemption (IDE) pivotal study underway for a transcatheter aortic valve replacement, and the only company to have both transfemoral and transapical transcatheter valve delivery systems commercially available in Europe.
Source: Edwards Lifesciences