October 14, 2008 - Edwards Lifesciences Corp. released new data from two studies of the Edwards SAPIEN transcatheter aortic heart valve with the RetroFlex transfemoral delivery system at TCT 2008.
The 30-day results from the European post-CE Mark SOURCE registry of 303 transfemoral patients demonstrated a survival rate of 94 percent. SOURCE is designed to evaluate the use of the Edwards SAPIEN valve in a hospital’s first 10 commercial cases, following Edwards’ prescribed training program. The majority of the SOURCE cases at 34 independent cardiac intervention centers were not proctored.
The second study, PARTNER EU, is an observational multicenter study conducted in Europe from April 2007 through January 2008 that enrolled 54 transfemoral patients. Interim follow-up results demonstrated a 92 percent survival rate at 30 days and 90 percent survival at six months. Had these very ill patients been treated with traditional open-heart surgery, the 30-day predicted survival would have been 75 percent.
Separately, in the U.S., Edwards reportedly is the only company to currently have underway a pivotal clinical trial of a transcatheter aortic valve replacement. This multicenter study includes both transfemoral (from the leg) and transapical (between the ribs) delivery systems for the transcatheter valve replacement. Edwards reportedly is also the only company to have both delivery system approaches for this procedure; valve delivery with either approach is performed while the heart continues to beat and without open-heart surgery or cardiopulmonary bypass.
The Edwards SAPIEN transcatheter heart valve is approved for commercial sale in Europe. In the U.S., it is an investigational device that is not available for sale.
For more information: www.edwards.com