Edwards' Sapien XT transcatheter aortic heart valve (Courtesy Edwards Lifesciences)
Edwards Lifesciences Corp. (Irvine, CA) has announced both the FDA approval and the U.S. launch of its next-generation Sapien XT transcatheter aortic heart valve for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS).
The Sapien XT heart valve has been commercially available for transcatheter aortic valve replacement (TAVR) for high-risk patients and those too sick for open-heart surgery in Europe since 2010, and received regulatory and reimbursement approval in Japan in 2013.
Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves, said in a press release, "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 continued, "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."
Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center and co-principal investigator for the Partner II trial which evaluated the Sapien XT valve, said in a second press release, "(t)he 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."
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The Sapien XT is the successor to the first-generation Sapien device, which was the first nonsurgical alternative to aortic valve replacement. Medtronic's CoreValve, a competing device, was approved earlier this year. According to Forbes magazine,"(t)he Sapien XT is expected to be more competitive, in part because of its lower profile and the availability of a 29 mm valve size for patients with a larger native annulus."
Edwards has said the Sapien XT will be immediately available "at leading U.S. cardiovascular centers," along with its accompanying transfemoral, transapical, and transaortic delivery systems.
As we reported less than a month ago, Edwards and Medtronic have agreed to settle their transcatheter heart valve patent infringement litigation for a total of up to $1.23 billion over the next eight years.
Stephen Levy is a contributor to Qmed and MPMN.
