Postmarket Data Presented for Edwards Sapien Valve

May 25, 2010—Edwards Lifesciences (Irvine, CA) announced that Martyn Thomas, MD, presented 1-year data from the company's SOURCE registry at the EuroPCR 2010 conference in Paris. Dr. Thomas reported that the Edwards Sapien transcatheter heart valve demonstrated promising 1-year mortality rates for high-risk patients, many of whom were too sick to undergo open heart surgery. At 1 year, there was an 81.1% survival rate in transfemoral procedures and a 72.1% survival rate in transapical procedures.

According to the company, the 1,038-patient SOURCE registry includes 1-year adjudicated data on consecutive patients treated with transcatheter heart valves with either a transfemoral or transapical approach. The registry includes outcome data from 100% of patients treated with the Edwards Sapien transcatheter heart valve at 32 European centers from November 2007 to January 2009 in its initial Cohort 1. One-year follow-up data were obtained for 98% of studied patients. Dr. Thomas also announced that 30-day results on an additional cohort of 1,301 patients (Cohort 2) that were enrolled in 2009 will be reported in the fall.