Commercialization readiness of a pulmonary flow restrictor for hypoplastic left heart syndrome

The National Heart, Lung, and Blood Institute awarded Starlight Cardiovascular, Inc. $499,952 under the Cardiovascular Diseases Research program (CFDA 93.837) on August 10, 2026, to advance commercialization of a catheter-delivered, adjustable percutaneous pulmonary flow restrictor designed to replace surgical pulmonary artery banding in newborns with hypoplastic left heart syndrome and other congenital heart defects.

The flow restrictor addresses clinical limitations of current surgical banding, which requires open-chest surgery and can impair pulmonary artery growth. Starlight is developing a device that reduces overcirculation to the pulmonary bed while maintaining systemic circulation balance, enabling affected infants to survive early critical weeks, minimize pulmonary artery damage, and grow stronger before subsequent corrective surgery. Pediatric interventional cardiologists have demonstrated interest in percutaneous alternatives; some currently perforate vascular plugs for off-label use, but these hand-modified devices suffer from extended implant lengths, lack of adjustability, unreliability, migration risk, and thrombosis concerns. Starlight's device is engineered to overcome these technical shortcomings and provide a manufactured, FDA-approvable alternative.

The award period runs through July 31, 2027, with performance in San Diego, California. This is a Project Grant under the SBIR program component, which emphasizes technological innovation and private-sector commercialization of federally funded research.

Abstract

Starlight cardiovascular is developing what will be the first FDA approved percutaneous flow restrictor to replace surgical banding in babies born with congenital heart disease (CHD). Many babies with chds such as hypoplastic left heart syndrome and communicating heart defects have overcirculation to the lower-resistance pulmonary bed and undercirculation to the rest of the body. Reducing pulmonary artery flow in these babies creates a more physiologic balance between pulmonary and systemic circulations and allows them to survive the first few weeks of life, reduces damage to their pulmonary arteries, and enables them to grow larger and stronger prior to their next, more invasive surgery to repair their heart defect. Currently, the reduction of pulmonary blood flow in these neonatal patients is achieved by surgical pulmonary artery banding, but banding requires an open-chest surgery and can interfere with pulmonary artery growth, thus limiting its clinical utility. A percutaneous solution could eliminate an open chest surgery for a newborn. Pediatric interventional cardiologists have so much interest in overcoming the negative effects of banding that they are perforating vascular plugs to create hand-made percutaneous pulmonary flow restrictors, and early clinical use of these devices have produced promising results. However, use of these modified vascular plugs is limited by technical challenges such as long implant lengths, lack of adjustability and reliability, device migration, and designs that increase thrombosis risk. Additionally, most clinicians are uncomfortable with modifying an occluder by hand and using IT off-label. Starlight cardiovascular is developing a catheter-delivered, percutaneous, and adjustable branch pulmonary artery blood flow restrictor to replace surgical banding in babies. Our device addresses the shortcomings from previous attempts at a percutaneous flow restrictor by providing reliable flow reduction, percutaneous adjustability, beneficial hemodynamics, and a short and well-anchored implant design that is removable. These pulmonary flow restrictors could benefit as many as 130,000 babies born each year with chds including hypoplastic left heart syndrome, ventricular septal defects, and truncus arteriosus. This CRP sbir grant will consist of developing processes to manufacture the device and performing biocompatibility testing needed to submit an investigational device exemption to FDA to begin a clinical trial of the device. Successful completion of this project will produce a final device that is ready for a clinical trial to support FDA approval and device commercialization.