OneValve: Non clotting, tissue-inductive prosthetic heart valve

William Wagner, PhD Professor of Surgery
Professor of Chemical and Petroleum Engineering
Professor of Bioengineering
Director of the McGowan Institute for Regenerative Medicine
Antonio D'Amore, PhD Research Associate
RiMED Fellow
Departments of Surgery and Bioengineering
McGowan Institute for Regenerative Medicine
Vinay Badhwar, MD Professor and Division Chief of Cardiothoracic Surgery, West Virginia University
Executive Chair, WVU Heart and Vascular Institute

Over 83,000 life-saving prosthetic valve operations were performed in the US in 2014 with an average cost of $164k/procedure and $192k/procedure for re-replacement. The global valve market is expected to surpass $ 4.9 B in 2017. There are two types of prosthetic heart valves for replacement: mechanical and bioprosthetic. Mechanical valves are very durable, but patients require daily anticoagulant therapy because of an increased risk of thrombosis. Bioprosthetic valves do not require anticoagulant therapy, but have other drawbacks, particularly leaflet calcification, which limits durability and necessitates re-replacement. Both options elevate the risk of endocarditis, a life-threatening infection of the inner heart lining. OneValve aims to address the limitations of current prosthetics. OneValve is a polyurethane heart valve (depicted: mitral valve prototype) that is non-thrombogenic, and capable of mimicking native valve mechanics, micro-structure, anatomy and function in all positions. Most importantly, the polyurethane core is replaced over time by functional host tissue without calcifying. Animal studies have yielded exciting results showing that the polyurethane valve will work well, reduce complications, reduce healthcare costs, and save thousands of lives. Once it achieves clearance and commercialization, OneValve will define a new generation of valvular heart disease technology, expanding the cardiac surgeon’s ability to save lives efficiently while minimizing complication risks.