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Direct Flow Medical, Inc. Receives CE Mark For First Fully Repositionable 29 mm Transcatheter Aortic Valve System


1/9/2014 10:58:06 AM

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SANTA ROSA, Calif.--(BUSINESS WIRE)--Direct Flow MedicalĀ®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, announced today it has received CE Mark for the first fully repositionable 29mm transcatheter aortic heart valve, delivered through its flexible, 18 French transfemoral delivery system. The Direct Flow Medical valve is designed to virtually eliminate aortic regurgitation in all sizes of annulus by allowing complete assessment of hemodynamic performance and unlimited repositioning of the valve after full deployment in the native valve annulus. The approval expands the population of patients who can be treated using the Direct Flow Medical valve to patients with annulus sizes ranging from 21mm to 28mm.

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