# DUCTUS ARTERIOSUS STENT TO IMPROVE CONGENITAL HEART DEFECT MORTALITY

> **NIH NIH R43** · STARLIGHT CARDIOVASCULAR, INC. · 2021 · $492,571

## 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 coronary artery stents for the ductus, and all-cause ductus reintervention is 47%.
The alternative is surgery on a neonate to place a shunt that carries a 7.2% risk of morbidity and
13.1% risk of mortality in the US. Starlight Cardiovascular proposes creating and commercializing
the first FDA-approved 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. This Phase I project involves
developing test fixtures, stent prototyping and testing, and a preclinical animal study. Due to the
variability of ductus anatomy, at least six benchtop anatomical models will be developed from 3D
computational models of patient-specific anatomy. Starlight's stent and delivery systems will then
undergo numerous iterations of designing, building and benchtop testing using the anatomical
models to optimize the stent designs for deliverability, placement accuracy and radial force
tailored to the challenging ductus anatomy. To select the final stent and delivery system design,
the most promising stent designs will be implanted acutely in neonatal lambs to evaluate their
performance in vivo. This Phase I project will result in the ultimate selection of the best ductus
arteriosus stent and delivery system design to undergo design validation testing in Phase II in
preparation for FDA approval.

## Key facts

- **NIH application ID:** 10323573
- **Project number:** 1R43HL158304-01A1
- **Recipient organization:** STARLIGHT CARDIOVASCULAR, INC.
- **Principal Investigator:** Beverly Tang
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $492,571
- **Award type:** 1
- **Project period:** 2021-08-06 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10323573

## Citation

> US National Institutes of Health, RePORTER application 10323573, DUCTUS ARTERIOSUS STENT TO IMPROVE CONGENITAL HEART DEFECT MORTALITY (1R43HL158304-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10323573. Licensed CC0.

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