DUCTUS ARTERIOSUS STENT TO IMPROVE CONGENITAL HEART DEFECT MORTALITY

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% risk of morbidity and 7% risk of mortality, even in the United States. Starlight Cardiovascular has created a 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 has been demonstrated, and a Phase II SBIR is underway to complete the formal preclinical testing of the device. This Phase IIB SBIR application proposes undertaking a clinical trial that will support FDA approval. A single arm study of forty infants with congenital heart disease and ductal dependent circulation will be enrolled in the trial at up to ten sites. Subjects will be followed for 180 days or until their planned second surgery. Results of primary safety and efficacy outcome measures will be obtained and compared against predetermined performance goals. This Phase IIB project will determine the safety and efficacy of the ductus arteriosus stent system. If the trial is successful, Starlight Cardiovascular will seek FDA approval and commercialization of the first ductus arteriosus stent in the United States.