Edwards Lifesciences Presents Updates From Transcatheter Valve Studies

September 21, 2009—Edwards Lifesciences Corporation (Irvine, CA) announced new clinical data demonstrating 100% freedom from structural deterioration of the Edwards Sapien valve at 18 months, as well as positive midterm patient outcomes resulting from the application of learning from earlier clinical programs. The data were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium in San Francisco.

According to the company, the study was conducted with Canadian compassionate-use patients, who were considered either nonoperable or at very high surgical risk for the treatment of severe aortic stenosis. In these patients, the Kaplan-Meier curve at 24 months demonstrated survival of 65% in transfemoral procedures and 64% in transapical procedures. There was a nearly even distribution of transfemoral procedures (49%) and transapical procedures (51%) 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," commented lead investigator Josep Rodés-Cabau, MD. "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."

Also at TCT, Edwards announced the most recent analysis of the data on 130 patients enrolled in the PARTNER EU clinical trial in Europe, which for many trial sites was their first transcatheter valve experience and the first time the multidisciplinary 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 functional classification system.

Edwards Lifesciences advised that in the United States, the Edwards Sapien transcatheter aortic heart valve is an investigational device being studied as part of the randomized, controlled PARTNER trial.