September 21, 2009 – Edwards Lifesciences Corp. today announced new clinical data demonstrating 100 percent freedom from structural deterioration of the Edwards SAPIEN valve at 18 months, as well as positive midterm patient outcomes resulting from the application of learnings from earlier clinical programs. The data were presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
For Canadian compassionate use patients, who were considered either nonoperable or at very high surgical risk for the treatment of severe aortic stenosis, the Kaplan-Meier curve at 24 months demonstrated survival of 65 percent in transfemoral procedures (valve delivered via the femoral artery), and 64 percent in transapical procedures (valve delivered via a small incision between the ribs). There was a nearly even distribution of transfemoral procedures (49 percent) and transapical procedures (51 percent) in the 339 patients receiving the transcatheter valve between January 2005 and June 2009. Patients treated at Canadian hospitals as part of the PARTNER Trial were excluded from the analysis.
“The Edwards valve was associated with positive acute and midterm results in very high-risk patients across Canada, and our findings illustrate high device success. These data encompass our earliest experience with the retrograde transfemoral delivery system, our first use of the transapical approach, and our first experience in Canada in utilizing a partnership between interventional and surgical valve specialists to screen and determine treatment approaches for patients,” said lead author Josep Rodés-Cabau, M.D., interventional cardiologist at the Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada, who provides consulting services to Edwards Lifesciences as an educator and trainer for Edwards SAPIEN transcatheter valve procedures.
Also announced today at TCT was the most recent analysis of the data on 130 patients enrolled in the PARTNER EU clinical trial, which for many trial sites was their first transcatheter valve experience and the first time the multi-disciplinary clinical partnership was used. The PARTNER EU study demonstrated continued positive quality of life measures at 12 months, including meaningful improvements in physical and mental well-being, and sustained gains in physical activity as measured by the New York Heart Association (NYHA) functional classification system.
“Today’s presentations at TCT continue to tell the story of the Edwards SAPIEN valve’s progress, from early experiences with a multi-disciplinary partnership, to successful regional expansion, to the deeper insights we gather from Edwards’ nine clinical programs that are complete or underway,” said Michael A. Mussallem, Edwards’ chairman and CEO.
Representatives from Edwards will be at booth 1011 at TCT beginning Sept. 23. The Edwards SAPIEN valve is approved for commercial sale in Europe. In the United States, it is an investigational device being studied as part of the PARTNER Trial, the world's only randomized controlled clinical trial of a transcatheter aortic heart valve.
For more information: www.edwards.com