Reduced Leaflet Motion in Bioprosthetic Aortic Valves — The FDA Perspective
John C. Laschinger(Center for Devices and Radiological Health), Changfu Wu(Center for Devices and Radiological Health), Nicole G. Ibrahim(Center for Devices and Radiological Health), Jeffrey Shuren(Center for Devices and Radiological Health)
Cited by 49Open Access
Abstract
The incidence and mechanism of reduced leaflet motion in bioprosthetic aortic valves and the accompanying risks cannot yet be fully characterized. Whether it is clinically meaningful or merely an advanced-imaging phenomenon demands additional investigation.
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