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Treatment options for patients with severe symptomatic aortic stenosis continue to expand with the FDA's approval of the second-generation Sapien XT transcatheter heart valve.
The approval on Monday of the device made by Edwards Lifesciences applies both to patients who are too sick to undergo surgical replacement of the aortic valve, and to those who are eligible for but at high risk from surgery.
The FDA made the decision after reviewing data from the randomized PARTNER II trial and from several registries, including the SOURCE XT registry from Europe -- where the valve has been available commercially since 2010 -- and the Society of Thoracic Surgeons/American College of Cardiology , Jeffrey Shuren, MD, JD, director of the agency's Center for Devices and Radiological Health, .
"We approved the Sapien XT transcatheter heart valve 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," he noted, adding that a "variance" was used to allow the approval.
"This is a rarely used regulatory action that is employed only in special situations of public health need," Shuren wrote, explaining that the agency's concerns were eased by the need for the new technology, the reasonable assurance of safety and efficacy, and the fact that Edwards provided a plan to address the problems found during the inspection.
Transcatheter aortic valve replacement (TAVR) options have increased dramatically since the beginning of the year, when only the first-generation Sapien valve was available.
Medtronic's CoreValve was approved for use in inoperable patients in January and then in high-risk patients last week. The availability of CoreValve could have been drastically limited due to patent disputes with Edwards, but the companies settled their legal differences last month, clearing the way for both companies' devices.
Compared with the first-generation Sapien valve, the Sapien XT valve has a lower profile and adds a 29-mm size to the 23-mm and 26-mm sizes available with Sapien. For comparison, CoreValve comes in 23-mm, 26-mm, 29-mm, and 31-mm sizes.
"With the additional availability of two transcatheter heart valve systems, physicians will now be able to treat the widest possible spectrum of patients with severe and symptomatic aortic stenosis," Shuren said in his blog post.