The FDA has given Direct Flow Medical the go-ahead to launch a feasibility study of its Transcatheter Aortic Heart Valve System, which consists of a distinctive metal-free heart valve implanted transfemorally using a flexible, 18-French delivery device. The trial will involve 30 aortic stenosis patients from as many as six clinical sites in the U.S.
Direct Flow gets FDA OK for aortic heart valve study
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