Edwards Lifesciences Corporation has chosen EuroPCR 2012 in Paris at which to proclaim that data from its Sapien XT transcatheter heart valve post-approval study demonstrated positive outcomes for high-risk patients. The data document the outcomes of 2,706 consecutively enrolled patients from 94 European centres,which the company says represents more than 20 percent of the total patients treated with commercially available Sapien XT valves during the time period of this study.
The SOURCE XT Registry enrolled patients treated with the Sapien XT valve in 17 countries between July 2010 and October 2011. Patients were treated using a transfemoral (n=1,694), transapical (n=906), transaortic (n=98) or subclavian (n=8) approach and will be followed out to five years.
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 percent and low rates of procedural complications. All-cause mortality for transfemoral patients (n=1,694) was 4.3 percent and 9.7 percent for patients treated with all other access routes (n=1,012).
“We are pleased that Heart Teams in Europe continue to achieve positive outcomes with this important therapy in high-risk patients,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter valve replacement. “Data from this rigorous post-approval study demonstrate the disciplined approach to patient selection that clinicians have maintained in a real-world setting.”
CE Mark for a further size
Edwards also announced at EuroPCR the receipt of CE Mark for 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, enabling Heart Teams to treat a broader population of transcatheter valve patients better served by a larger valve.
US regulatory status
The Edwards SAPIEN XT valve and the NovaFlex+ transfemoral delivery system are investigational devices not yet available commercially in the United States.
Source: Edwards Lifesciences, Marketwire