Postmarket SOURCE Registry Data Show Successful 1-Year Outcomes for Edwards Sapien Valve

May 20, 2011—Edwards Lifesciences Corporation (Irvine, CA) announced that data from the postmarket European SOURCE registry studying the first 2 years of commercialization of the Edwards Sapien valve were presented at the EuroPCR 2011 conference in Paris. The company stated that with more than 2,300 patients enrolled in SOURCE since November 2007, clinicians continued to achieve successful 1-year outcomes in high-risk or inoperable patients undergoing transcatheter aortic valve replacement with the Sapien device.

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% of patients. In cohort I, there were 463 transfemoral and 575 transapical procedures; in cohort II, there were 457 transfemoral and 812 transapical procedures. Olaf Wendler, MD, and Martyn Thomas, MD, are the Principal Investigators of the SOURCE registry.

Edwards stated that despite high predicted mortality and multiple comorbidities in many of these patients, survival at 1 year was 76% in the 1,038 patients treated as part of cohort I (first year of commercialization) and 77% in the 1,269 patients treated as part of cohort II (second year of commercialization). For all of the patients in both cohorts, the 1-year survival rate was 80.1% for those receiving transfemoral valve replacement and was 74.2% for transapical. The company also noted that EuroSCORE-predicted 30-day operative mortality was similar for patients in the first and second years of commercialization, with means of 27.6 and 25, respectively.

Also at EuroPCR, Edwards announced the receipt of CE Mark approval for 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 before 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 company advised that the Edwards Sapien valve, Edwards Sapein XT valve, NovaFlex+, and eSheath are investigational devices not yet available commercially in the United States.