The Direct Flow Medical (DFM) percutaneous aortic valve is designed to have the performance (function, durability and safety) of a surgical valve while incorporating the desirable attributes for transcatheter delivery with the additional ability to be positioned, repositioned and completely retrieved if necessary.
The bovine pericardial leaflets are attached to an inflatable polyester fabric cuff which conforms to the native aortic valve annulus and left ventricular outflow tract to form a seal to minimize the potential of paravalvular leak. The implant is designed with independently inflatable ventricular and aortic rings, which encircle and capture the native valve annulus to provide positive axial anchoring of the device. Inflation of the cuff with a saline and contrast solution renders the valve immediately functional and permits fluoroscopic visualization. Before final deployment, the saline and contrast mixture is exchanged under pressure, maintaining cuff shape and position, with a solidifying inflation media (IM) that hardens to form the permanent support structure.