European Registry of 2,300 Transcatheter Valve Patients Shows Good One-Year Outcomes


May 20, 2011

May 20, 2011 - Edwards Lifesciences Corporation 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.

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.

Also today at EuroPCR, Edwards announced the receipt of CE Mark approval for sale in the European Union of the NovaFlex+ transfemoral delivery system for use with the next-generation Edwards SAPIEN XT transcatheter heart valve. This new system incorporates modifications focused on improving ease of use and is designed to make valve alignment prior to deployment more reliable. Edwards is launching this system, as well as the eSheath expandable sheath technology, at EuroPCR. The eSheath, which received CE Mark earlier this year, enables the use of a low profile sheath and is designed to reduce vascular complications. The Edwards SAPIEN valve, Edwards SAPIEN XT valve, NovaFlex+ and eSheath are investigational devices not yet available commercially in the United States.

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