Direct Flow gets FDA OK for aortic heart valve study

05/21/2013 |

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.

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