Premature infants with hemodynamically significant patent ductus arteriosus suffer increased mortality and significant morbidity. A minimally invasive, catheter based treatment strategy would be attractive. Project Goals The goal of the project is to develop an implantable patent ductus arteriosus closure device to be safely delivered through the peripheral vasculature of a premature infant. First, a prototype would be developed and tested in animals, and ultimately a clinical-grade device would undergo regulatory development for clinical testing at NIH. Offerors are encouraged to include concrete milestones in their proposals, along with detailed research and development plans, risk analysis, and contingency plans, both for Phase I and Phase II. It is recognized that available animal models may not match the desired human in vivo geometry of the device. Offerors are advised to plan for travel to NHLBI in Bethesda Maryland, and are expected to plan meetings at project initiation, mid-project to determine what iteration is necessary, and at project completion.
