Edwards Receives CE-Mark Approval for 29-mm Sapien XT Valve and Presents SOURCE XT Registry Data

May 17, 2012—At the EuroPCR 2012 conference in Paris, Edwards Lifesciences Corporation (Irvine, CA) announced receipt of CE Mark approval for European commercial sales of its 29-mm Sapien XT heart valve delivered with the NovaFlex+ transfemoral delivery system. Edwards also announced that data from the SOURCE XT postapproval registry for the Edwards Sapien XT transcatheter heart valve were presented at EuroPCR 2012.

As detailed in Edwards' press release, the SOURCE XT registry data demonstrated positive 30-day outcomes for high-risk patients treated with the Sapien XT device, including low all-cause mortality of 6.3% and low rates of procedural complications. All-cause mortality for transfemoral patients (n = 1,694) was 4.3% and 9.7% for patients treated with all other access routes (n = 1,012).

According to the company's announcement, the monitored and adjudicated prospective SOURCE XT registry is studying the Sapien XT valve in a real-world commercial setting. It involves 94 European centers performing transcatheter aortic valve replacement.

The data presented at EuroPCR 2012 document the outcomes of 2,706 consecutively enrolled patients, which represents more than 20% of the total patients treated with commercially available Sapien XT valves during the time period of the study.

The registry enrolled patients who were treated with the Sapien XT valve in 17 countries between July 2010 and October 2011; the enrolled patients will be followed out to 5 years. Patients were treated using a transfemoral (n = 1,694), transapical (n = 906), transaortic (n = 98), or subclavian (n = 8) approach, stated Edwards Lifesciences.