Inflatable Aortic Valve Reduces Aortic Regurgitation

An innovative transcatheter aortic valve (TAV) system virtually eliminates aortic regurgitation with no vascular complications.

The Direct Flow Medical (DFM) TAV System percutaneous aortic valve is designed to have the performance of a surgical valve with the attributes for transcatheter delivery, with the additional ability to be positioned, repositioned, and completely retrieved if necessary. The valve is based on an inflatable cuff with a conforming polymer support structure. Inflatable ventricular and aortic rings at the top and bottom of the valve are designed to conform and seal above and below the native valve. The lack of a metallic frame allows for a low profile, flexible, fully-sheathed system with the potential to reduce bleeding and vascular complications, particularly in patients with tortuous and variable anatomy. The valve is endovascularly delivered via a six mm introducer sheath.


The independently inflatable rings 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. Full-thickness bovine pericardial leaflets are incorporated in the valve design for durability. The DFM TAV System is a product of Direct Flow Medical (Santa Rosa, CA, USA), and is currently approved as an investigational device.

“We designed the Direct Flow Medical System specifically to address complications that were problematic with earlier generations of transcatheter aortic heart valves,” said Charles Davidson, MD, clinical chief of cardiology at Northwestern Memorial Hospital (Chicago, IL, USA), and chief medical officer of Direct Flow Medical. “Our proprietary design takes a very different approach to restoring valvular flow, while being fully repositionable and retrievable.”

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Direct Flow Medical
Northwestern Memorial Hospital