# Commercialization Readiness for Ductus Arteriosus Stent to Improve Congenital Heart Defect Mortality

> **NIH NIH SB1** · STARLIGHT CARDIOVASCULAR, INC. · 2024 · $500,000

## Abstract

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 CRP SBIR application proposes finalizing the manufacturing processes,
manufacturing devices for clinical use, and obtaining Investigational Device Exemption (IDE) approval from FDA
to begin a clinical trial. This CRP project will enable Starlight to move into clinical testing for its 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.

## Key facts

- **NIH application ID:** 11006856
- **Project number:** 1SB1HL176266-01
- **Recipient organization:** STARLIGHT CARDIOVASCULAR, INC.
- **Principal Investigator:** Beverly Tang
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $500,000
- **Award type:** 1
- **Project period:** 2024-09-15 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11006856

## Citation

> US National Institutes of Health, RePORTER application 11006856, Commercialization Readiness for Ductus Arteriosus Stent to Improve Congenital Heart Defect Mortality (1SB1HL176266-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11006856. Licensed CC0.

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