September 2, 2009 – Edwards Lifesciences Corp. said this week it completed enrollment in its 1,040-patient randomized controlled investigational device exemption (IDE) study of the Edwards SAPIEN transcatheter heart valve.
In addition to completing enrollment in both the surgical and nonsurgical arms of the PARTNER Trial, Edwards received U.S. Food and Drug Administration (FDA) IDE approval for nonrandomized continued access to the Edwards SAPIEN valve for actively enrolling PARTNER sites.
"It's exciting that the clinical community will soon have the opportunity to make an informed evaluation of this treatment against conventional therapies that may not be realistic options for high-risk patients with severe aortic stenosis," 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 coprincipal investigator for the trial.
The multicenter PARTNER (Placement of AoRTic traNscathetER valves) Trial assigns patients into one of two arms: a "nonsurgical" 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 primary endpoint for the PARTNER Trial is based on one-year follow-up of each patient enrolled; this evaluation has been underway and is continuing.
"The PARTNER Trial has brought together multidisciplinary clinical teams aligned around the mission of addressing the serious problem of aortic stenosis by treating patients with a far less invasive, transcatheter approach," said Martin B. Leon, M.D., associate director of the Cardiovascular Interventional Therapy (CIVT) Program at NewYork-Presbyterian Hospital/Columbia University Medical Center, professor of medicine at Columbia University College of Physicians and Surgeons, and coprincipal investigator for the PARTNER Trial.
Edwards is the only company to have both transfemoral and transapical transcatheter valve delivery systems commercially available in Europe. The Edwards SAPIEN valve was approved for sale in Europe in late 2007, and has been used in the treatment of thousands of high-risk patients and evaluated as part of nine rigorous scientific studies. New clinical data on the Edwards SAPIEN valve will be presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, Sept. 21-25.
For more information: www.edwards.com