Novel Percutaneous Aortic Heart Valve and Delivery System – IP 0711

According to the American Heart Association’s 2006 Heart and Stroke Statistical Update, valvular heart disease is responsible for nearly 20,000 deaths each year in the United States and is a contributing factor in about 42,000 deaths, with a majority of these cases involving disorders of the aortic valve (63 percent). Unfortunately, many of these deaths could have been prevented had there been a viable alternative to open heart surgery. Developers of percutaneous approaches to heart valve replacement are solving some of the current problems of open heart surgery, but have yet to address others. Therefore we set out to develop innovative products which address the challenges of other percutaneous procedures. Our research led us to two products. 1) A catheter deliverable artificial trileaflet heart valve prosthesis or percutaneous heart valve (PHV): Our PHV is comprised of two main elements; (a) an artificial polymer-based composite leaflet material; and (b) a self-expanding metal alloy stent or support/fixation structure. Our prototype currently utilizes a super-biostable polymer and a commercially available polyester mesh; however other polymers can be utilized. The stent is composed of super- elastic Nitinol wire, which has excellent biocompatibility and mechanical properties. Testing has indicated that our prototype is equally or more effective than our competitors. 2) A catheter-based percutaneous heart valve delivery system: This PHV delivery system is designed to complement any self-expandable PHV. It is comprised of a PHV crimping/loading tool, a catheter designed to facilitate PHV deployment, and a control hand piece that allows remote PHV deployment and catheter tip deflection or steering. Key features in our design are the crimping tool and the steering feature. There are no commercially available equivalents for the system at present. We have designed both products to be compatible with other products. Currently we are performing further bench testing, and are looking to enter animal trials. Shantanu Balkundi sbalkund@fiu.edu 305-348-8061

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