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FDA clears Edwards Lifesciences Sapien XT valve

Edwards Lifesciences has received United States Food and Drug Administration (FDA) approval for its Edwards Sapien XT transcatheter aortic heart valve.

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The valve is used to treat high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS).

Including the 29mm valve size for patients with a large native annulus, the Edwards Sapien XT valve is expected to enable the treatment of more patients.

Sapien XT will be immediately available to patients at select cardiovascular centers across the US, along with the NovaFlex+ transfemoral delivery system and the Ascendra+ transapical and transaortic delivery systems, according to the company.

The PARTNER II Trial co-principal investigator Dr. Martin Leon said 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.

"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," Leon added.

The PARTNER II Trial was Edwards’ second randomized controlled trial of a transcatheter valve and evaluated the Sapien XT valve.

Edwards Lifesciences transcatheter heart valves corporate vice president Larry Wood said clinicians have demonstrated their confidence in the Sapien valves by making them the market-leading transcatheter valves, and this approval provides greater options for U.S. patients who can benefit from the substantial enhancements in this proven platform.

"The SAPIEN family of valves has been used in the treatment of more than 70,000 patients globally – with the majority of those patients treated with SAPIEN XT – and we look forward to Heart Teams across America transforming the lives of even more patients with this advanced transcatheter valve," Wood added.

Commercially available in Europe since 2010, the Edwards Sapien XT valve received the Japanese regulatory and reimbursement approval in 2013.

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Image: Edwards Lifesciences’ Sapien XT transcatheter aortic heart valve. Photo: Courtesy of PRNewswire.