Browsing by Subject "aortic valve stenosis"
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Considerations and recommendations for the introduction of objective performance criteria for transcatheter aortic heart valve device approval
(Ovid Technologies (Wolters Kluwer Health), 2016-05-23)In the United States, new surgical heart valves can be approved on the basis of objective performance criteria (OPC). In contrast, the US Food and Drug Administration traditionally requires stricter criteria for transcatheter ...