DUCTUS ARTERIOSUS STENT TO IMPROVE CONGENITAL HEART DEFECT MORTALITY

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ABSTRACT The technical challenges faced by pediatric cardiovascular physicians (surgeons and interventionalists alike) have long been ignored, forcing them to use devices designed for adults and different conditions to treat ailing babies with very specific anatomical considerations. One such case is in the sustained opening of the ductus arteriosus, a natural conduit that exists in all newborns but closes shortly after birth. In certain congenital heart defects, it is crucial to maintain ductus patency for the newborn to survive without surgical intervention. There is no ductus arteriosus stent commercially available in the US. Pediatric interventional cardiologists currently repurpose adult coronary artery stents for the ductus, and all-cause ductus reintervention is 47%. The alternative is surgery on a neonate to place a shunt that carries a 7.2% risk of morbidity and 13.1% risk of mortality in the US. Starlight Cardiovascular proposes creating and commercializing the first FDA-approved ductus arteriosus stent that is specifically designed to address the challenges facing treating physicians, including a right-sized delivery system, end-to-end coverage of the ductus, navigation and deployment through tortuous ductus anatomy, and precise placement to avoid stent protrusion into the aorta and pulmonary arteries. A stent designed and tested specifically for this purpose has the potential to decrease reinterventions, morbidity, and potentially mortality for babies with ductal-dependent circulation. This Phase I project involves developing test fixtures, stent prototyping and testing, and a preclinical animal study. Due to the variability of ductus anatomy, at least six benchtop anatomical models will be developed from 3D computational models of patient-specific anatomy. Starlight's stent and delivery systems will then undergo numerous iterations of designing, building and benchtop testing using the anatomical models to optimize the stent designs for deliverability, placement accuracy and radial force tailored to the challenging ductus anatomy. To select the final stent and delivery system design, the most promising stent designs will be implanted acutely in neonatal lambs to evaluate their performance in vivo. This Phase I project will result in the ultimate selection of the best ductus arteriosus stent and delivery system design to undergo design validation testing in Phase II in preparation for FDA approval.