IRVINE, CA — The US Food and Drug Administration has approved the Sapien XT transcatheter aortic heart valve (Edwards Lifesciences) for the treatment of high-risk and inoperable patients with severe aortic stenosis. This is the next generation of the Sapien valve, first approved in November 2011.
The newest iteration of the valve is a lower-profile system and can be delivered transfemorally via a 16-French expandable sheath as well as with the Ascendra+ system for transapical delivery. It comes in 23-mm, 26-mm, and 29-mm sizes—the larger size allowing expanded use of this procedure in patients with a larger native annulus.
Evidence of device safety and efficacy comes from the PARTNER 2 trial, previously reported by heartwire , which suggested the lower-profile device is associated with a lower complication rate and improved outcomes compared with the first-generation valve.
Approval of the Sapien XT comes earlier than expected, according to several industry analysts, who predicted a delay due to an agency warning letter relating to one of the manufacturer's facilities as well as manufacturing and "validation" issues.
Late yesterday, however, the company announced the approval had been granted, news that was swiftly followed by a blog post by the FDA's director of Center for Devices and Radiological Health, Dr Jeffrey Shuren, explaining the agency's decision. In it, Shuren noted, "We approved the Sapien XT THV despite observing certain quality-system violations during a recent inspection at the Edwards manufacturing facility where the Sapien XT delivery systems and accessories are made. . . . When violations occur, according to federal law, we cannot approve a company's medical device—unless we allow deviation from quality-system requirements through what is known as a 'variance.' This is a rarely used regulatory action that is employed only in special situations of public-health need."
In this instance, Shuren continued, the agency decided to grant the variance because of the important and immediate need for the device and because Edwards had presented the agency with a plan for solving its manufacturing problems.
The FDA approval comes just days after the agency announced an expanded indication for another transcatheter aortic device, the CoreValve.
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Cite this: FDA Approves Next-Generation Transcatheter Valve Sapien XT - Medscape - Jun 17, 2014.