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 stents for the ductus, and all-cause ductus reintervention is 47%. The alternative is open-chest surgery on a neonate to place a shunt that carries a 13.1% risk of morbidity and 7.2% 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. The feasibility of the innovative stent system designed for pediatric applications using self-expanding technology was demonstrated in a successful Phase I through numerous rounds of bench testing, physician evaluations, and an animal study; and this Phase II application proposes finalizing the stent design and completing preclinical testing necessary for a clinical trial and FDA approval. Through rapid iterations, Starlight will begin by optimizing the stent system for design characteristics and manufacturability. Starlight will then complete a chronic GLP animal study in 16 newborn lambs to demonstrate stent patency over 180 days. Verification and validation (V&V) testing of all aspects of the stent system (including biocompatibility, sterilization, and mechanical testing) will then be performed in accordance with FDA guidance documents for endovascular stents. This Phase II project will result in a finalized ductus arteriosus stent system design that has passed all of the necessary preclinical testing required for a clinical trial and subsequent FDA approval through the Humanitarian Device Exemption pathway.