Starlight Cardiovascular is developing what will be the first FDA approved percutaneous flow restrictor to replacesurgical banding in congenital heart defects (CHD), including Hypoplastic Left Heart Syndrome (HLHS). Thepotential worldwide market for the Starlight Flow Restrictor is over $200M.Approximately 1,000 Americans are born each year with Hypoplastic Left Heart Syndrome (HLHS), a conditionwhere the left ventricle is severely underdeveloped or barely present. Babies born with HLHS require palliationsurgery, commonly a Norwood procedure, within days after birth to survive, subjecting the neonate tocardiopulmonary bypass and a costly, invasive surgery. A hybrid (half surgical and half percutaneous) palliationprocedure exists as an alternative, however a limitation of the hybrid procedure is reliable branch pulmonaryartery banding. Branch pulmonary artery banding requires an open surgery and can interfere with pulmonaryartery growth, necessitating pulmonary artery reconstruction surgery. Attempts at modifying existing devices tocreate percutaneous flow restrictors to replace surgical banding produced some promising clinical results.However use of these modified devices is limited by technical challenges such as large and stiff delivery systems,long implant lengths, lack of adjustability and reliability, and designs that increase thrombosis risk.Starlight Cardiovascular is developing a percutaneous and adjustable branch pulmonary artery blood flowrestrictor to replace surgical banding. Our device addresses the shortcomings from previous attempts at apercutaneous flow restrictor, by providing safe venous implant delivery, reliable flow reduction, percutaneousadjustability, beneficial hemodynamics, and a short and well anchored implant design that is removable. Thesepulmonary flow restrictors designed for HLHS can be modified to also replace main pulmonary artery banding,more than doubling the number of patients who could benefit.This Phase I SBIR grant will consist of computational fluid dynamics modeling and testing to inform devicedesign, benchtop model development, and final device design selection through end-user benchtop testing bypediatric interventional cardiologists. Successful completion of this project will produce a final device design thatis ready for animal testing, design refinement, and Verification and Validation testing in Phase II, which willprepare the flow restrictor device for a clinical trial, FDA Humanitarian Device Exemption approval, andcommercialization.
Public Health Relevance Statement: PROJECT NARRATIVE
Babies born with Hypoplastic Left Heart Syndrome (HLHS) require surgical intervention within days of life to
survive. Surgery is invasive and requires putting the baby on a heart-lung bypass machine, which can have
negative consequences. Starlight Cardiovascular will develop the first branch pulmonary artery flow restrictors
designed specifically for babies with HLHS that can be delivered percutaneously through a catheter, which could
replace surgery and improve patient outcomes with an increased safety profile.
Project Terms: <0-4 weeks old>
