Edwards Lifesciences Launching SAPIEN XT Valve In The U.S.
FDA Approval Includes High-Risk and Inoperable Indications, Transfemoral and Alternative Access Systems
IRVINE, Calif., June 16, 2014 — Edwards Lifesciences Corporation today announced that it has received United States Food and Drug Administration (FDA) approval for its Edwards SAPIEN XT transcatheter aortic heart valve for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS). This next-generation, lower-profile system, which includes the 29mm valve size for patients with a large native annulus, will allow for the treatment of more patients.
The Edwards SAPIEN XT valve will be immediately available to patients at leading cardiovascular centers across the nation, along with the NovaFlex+ transfemoral delivery system that can be delivered through a low-profile 16-French expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery systems.
"There is a substantial and growing body of evidence that the SAPIEN XT valve benefits both high-risk and inoperable patients, and clinicians have documented these consistently positive results in both randomized studies and European country registries," said Martin B. Leon, MD, director, Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center and professor of medicine at the Columbia University College of Physicians and Surgeons. Dr. Leon was the co-principal investigator for the PARTNER II Trial, which was Edwards' second randomized controlled trial of a transcatheter valve and evaluated the SAPIEN XT valve. "The results from the PARTNER II Trial in treating U.S. inoperable patients with the SAPIEN XT valve demonstrated a reduction in complications with the TAVR procedure, and improved patient outcomes over earlier trials."
The Edwards SAPIEN XT valve has been commercially available in Europe since 2010, and received regulatory and reimbursement approval in Japan in 2013.
Additional company information can be found at www.edwards.com .
Edwards, Edwards Lifesciences, the stylized E logo, Ascendra+, Novaflex+, eSheath, PARTNER II, SAPIEN and SAPIEN XT are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.