SBIR TOPIC 096: Novel Biodegradable Metal Stents for Neonatal Aortic Coarctation

Most stents used to repair congenital heart lesions only need to serve as temporary scaffoldingsBecause pediatric patients have growing cardiovascular structuresthere is great interest in use of bioresorbable stentsBRSfor the treatment of coarctation of the aorta in neonatesA pediatric bioresorbable stent would allow thousands of infants each year to avoid the morbidity and mortality of more invasive surgical proceduresThe PediaStent team includes the expertise needed to perform the required laboratory and animal testing of candidate BRSs and the experience needed to commercialize such a deviceTwo novel BRSsdeveloped at two separte academic centershave been identified for testing in Phase IA zinc alloy stent and a polymer coated nanocomposite magnesium stentPreliminary testing suggests that both stents offer the radial force and limited recoil required to successfully treat coarctation of the aorta in the neonatal period without the need for large introducer sheathsPhase I testing will include bench and animal testing to confirm that these devices have the characteristics needed to treat neonatal aortic coarctationThe Phase II study will include a GLP level animal study and bench testing using an ISOcertified research laboratoryAt the completion of Phase IIa single bioresorbable stent will be ready for first in human testing in a clinical trial in neonates