Edwards Lifesciences received FDA approval for its SAPIEN XT transcatheter aortic heart valve for implantation in patients with symptomatic aortic stenosis who are poor candidates for traditional surgery. The same device  has recently been approved in Europe for valve-invalve aortic and mitral procedures.

The SAPIEN XT is implanted using the NovaFlex+ system, that can be delivered via a 16-French expandable sheath, and the Ascendra+ transcapical and transaortic delivery systems. The new valve is available in sizes up to 29mm, allowing for treatment of patients with particularly large native annuli.

From the announcement:

“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.”

Source:Edwards Lifesciences