Development of a Polymeric Percutaneous Pulmonary Valve for Use in Young Children

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Project Summary: Congenital heart disease (CHD) remains the most common category of birth defect and a leading cause of childhood death in the developed world. Of the constellation of structural defects that comprise CHD, dysfunctional pulmonary valves (PV) are a common abnormality, and frequently require surgical intervention and replacement. Valve replacement through open heart surgery carries substantial risk and discomfort for patients, and represents a major financial and emotional burden for families. The most commonly used valves for pulmonary valve replacement in young children are biologically-derived (e.g. human cadaveric valves). Such replacements are in short supply, and have other inherent disadvantages, such as poor long-term durability, and propensity to induce a host immune response. The combination of these factors leads to a cycle of repeat surgical interventions, using valves that are scarcely available and destined for rapid failure. PolyVascular has sought to address these issues by developing a polymeric stent-mounted valve (SMV), comprised of polymer-derived leaflets mounted within a metal stent, that can be delivered via minimally invasive transcatheter techniques, avoiding the burden of repeat surgeries, with potential for improved durability and function. The present supplement is meant to support Dr. Larry Scott toward postdoctoral training in medical device development with PolyVascular, under PA-18-837. The proposal consists of two training components: in the Research Plan, Dr. Scott will employ methods under ISO 5840-3 to evaluate alternative materials for the proposed SMVs, across a range of sizes. He will gain training in device manufacture, hydrodynamic performance of the valves, and extended durability of the valves. All steps will be conducted under a quality system, and Dr. Scott will gain experience in adhering to this system. A second training component involves his Career and Mentorship Plan, in which Dr. Scott will take advantage of the startup ecosystem in the Texas Medical Center, through courses at Enventure and other local institutions. He will gain experience in entrepreneurship and responsible conduct of research, within the framework of device development for FDA approval. Both elements of his Research Plan are intended to avail Dr. Scott of an interdisciplinary team of researchers, and ready him for a career in medical device development.