# DEVELOPMENT OF A PULMONARY FLOW RESTRICTOR FOR HYPOPLASTIC LEFT HEART SYNDROME

> **NIH NIH R44** · STARLIGHT CARDIOVASCULAR, INC. · 2024 · $999,969

## Abstract

ABSTRACT
Starlight Cardiovascular is developing what will be the first FDA approved percutaneous flow restrictor to replace
surgical banding in 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, device migration, and lack of adjustability and reliability.
Additionally, many 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. Our device addresses the shortcomings from previous
attempts at a percutaneous flow restrictor by providing reliable flow reduction, percutaneous adjustability, 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 Phase II SBIR grant will consist of device design optimization through design iteration, benchtop testing,
end-user simulated use testing by pediatric interventional cardiologists, and acute and chronic animal studies.
Successful completion of this project will produce a final device design that is ready for formal Verification and
Validation testing, clinical studies, FDA approval, and commercialization.

## Key facts

- **NIH application ID:** 10920017
- **Project number:** 2R44HL162218-02A1
- **Recipient organization:** STARLIGHT CARDIOVASCULAR, INC.
- **Principal Investigator:** Beverly Tang
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $999,969
- **Award type:** 2
- **Project period:** 2022-02-15 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10920017

## Citation

> US National Institutes of Health, RePORTER application 10920017, DEVELOPMENT OF A PULMONARY FLOW RESTRICTOR FOR HYPOPLASTIC LEFT HEART SYNDROME (2R44HL162218-02A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10920017. Licensed CC0.

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