Edwards Sapien XT transcatheter valve shows positive patient outcomes in 94 centres post-approval study


Data presented on 17 May at EuroPCR from a post-approval study of the Edwards Sapien XT transcatheter heart valve (Edwards Lifesciences) for TAVI procedures demonstrated positive outcomes for high-risk patients. These data document the outcomes of 2,706 consecutively enrolled patients, representing more than 20% of the total patients treated with commercially available Sapien XT valves during the time period of this study. 

Thirty-day outcomes for patients enrolled in the SOURCE XT Registry, a monitored and adjudicated prospective registry studying the Edwards SAPIEN XT valve in a real-world commercial setting, demonstrated 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). The study involved 94 European centres.

At EuroPCR, Edwards Lifesciences announced the receipt of CE mark for European commercial sales of its 29 mm Sapien XT valve delivered with the NovaFlex+ transfemoral delivery system.  With this valve, Edwards’ transcatheter valve portfolio now offers three valve sizes for both transfemoral and transapical delivery.

Results from the early first-in-human experiences with Edwards’ two new transcatheter valve platforms will be presented during EuroPCR’s “Glimpse into the future” session on Friday 18 May, which is focused on emerging technologies for transcatheter aortic valve therapies. The Sapien 3 valve is Edwards’ next-generation balloon-expandable valve that builds upon the company’s knowledge and experience in TAVI and includes a unique feature designed to reduce paravalvular leaks. Centera, Edwards’ repositionable, self-expanding valve, features a motorised delivery system designed for stable deployment and single operator use. Both systems are low profile and able to be delivered through a 14-French eSheath, Edwards’ expandable introducer sheath.

The Sapien XT valve and the NovaFlex+ transfemoral delivery system are investigational devices not yet available commercially in the United States.  The Sapien 3 valve and Centera are investigational devices not yet available commercially in any country.