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Preclinical Testing of a New Venous Valve

Venous valvular incompetency is a debilitating disease affecting millions of patients. Unfortunately, the current physiologic and surgical treatments are prone to the extreme risk of post-operative thrombosis. A new design for venous valves has been proposed using biomimicry. The medical device has the shape of a natural valve with sufficient elasticity to maintain patency and competency in the leg veins. The venous valve was tested for patency, competency, cyclic fatigue, compressibility, and thrombogenicity. Patency is maintained with a low opening pressure of less than 3 mmHg. Competency is maintained with backpressures exceeding 300 mmHg. The valve is fatigue resistant to over 1⁄4 million cycles. The valve can maintain its integrity when compressed in a stent and deployed without tilting or mal-alignment. Little thrombus forms on the valve with perfusion of whole blood under pulsatile flow conditions. The preclinical tests demonstrate efficacy as a new venous valve for treatment of chronic venous insufficiency.