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Home » FDA Grants Expanded Indication for Transcatheter Heart Valves
FDA Grants Expanded Indication for Transcatheter Heart Valves
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August 19, 2019
The FDA has approved an expanded indication for several transcatheter heart valve devices to include patients with low risk of severe aortic valve stenosis, a valve disease problem in which the aortic valve’s opening narrows.
The transcatheter valves included in the agency’s decision — Edwards’ Sapien 3 and Sapien 3 Ultra and Medtronic’s CoreValve Evolut R and CoreValve Evolut Pro — had been indicated only for patients at mid- to higher risk of major complications or death during open-heart surgery.
The new approval “significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” said Bram Zuckerman, director of CDRH’s Office of Cardiovascular Devices.
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