PARIS--(Marketwire - May 20, 2011) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that clinicians continued to achieve successful one-year outcomes in high-risk or inoperable patients undergoing transcatheter aortic valve replacement during the first two years of commercialization of the Edwards SAPIEN valve. Data on the more than 2,300 patients enrolled in the post-market European SOURCE Registry since November 2007 were presented in a late-breaking clinical trial session today at EuroPCR 2011.

Despite high predicted mortality and multiple co-morbidities in many of these patients, survival at one year was 76 percent in the 1,038 patients treated as part of Cohort I (first year of commercialization), and 77 percent in the 1,269 patients treated as part of Cohort II (second year of commercialization). For all of the patients in both cohorts, the one-year survival for those receiving transfemoral valve replacement (via the femoral artery), was 80.1 percent, and for transapical patients (via a small incision between the ribs), it was 74.2 percent.

"By establishing the rigorous SOURCE post-market registry and continuing to follow the outcomes of patients into the second year of commercialization, we are better able to understand how this therapy is applied in a real-world setting, affirming our approach to its commercial introduction," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "Of note, EuroSCORE predicted 30-day operative mortality was similar for patients in the first and second years of commercialization, with a mean of 27.6 and 25, respectively."
The SOURCE Registry includes data from patients treated with the Edwards SAPIEN transcatheter heart valve at 32 European centers in its initial Cohort I, and 37 centers in Cohort II. One year follow-up data were obtained on 98 percent of patients. This is the largest reported experience in the world with data on consecutive patients within each hospital who were treated with transcatheter heart valves delivered transfemorally or transapically. In Cohort I, there were 463 transfemoral and 575 transapical procedures; in Cohort II, there were 457 transfemoral and 812 transapical procedures. The principal investigators of the SOURCE Registry are Olaf Wendler, M.D., Ph.D., clinical director for cardiology and cardiothoracic surgery, King's College Hospital, and Martyn Thomas, M.D., clinical director for cardiothoracics, Guy's and St. Thomas' NHS Foundation Trust.

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