Percutaneous Flow Restrictor for Hypoplastic Left Heart Syndrome (HLHS) in newborns
Official title: DEVELOPMENT OF A PULMONARY FLOW RESTRICTOR FOR HYPOPLASTIC LEFT HEART SYNDROME
Funded at Starlight Cardiovascular, INC. · NIH-11292148 · Data updated 2026-11-12
A new device-based approach aims to safely limit blood flow to the lungs in very young patients with HLHS, potentially avoiding risky open-heart surgery.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Starlight Cardiovascular, INC. NIH-funded |
| Lab location | 1 site (San Diego, UNITED STATES) |
| Project start | February 15, 2022 |
| Project end | July 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $1,166,665 |
| NIH project number | 2R44HL162218-04 |
| Project ID | NIH-11292148 on NIH RePORTER |
Who could benefit from this research
✓Could help
Newborns with HLHS or similar CHD who require reduced pulmonary blood flow as part of initial management.
✕Less likely to help
Patients without HLHS or those not needing pulmonary flow restriction may not benefit.
What this research studies
This project develops a first-in-FDA-approved percutaneous device to reduce pulmonary blood flow in newborns with congenital heart defects like HLHS. By avoiding open-chest banding, the device could improve survival and growth by balancing pulmonary and systemic circulation in the critical neonatal period. The study builds on early experiences with hand-made devices and aims to address issues like implant length, adjustability, and reliability to make a safer, minimally invasive option for infants. If successful, it could shorten recovery times and reduce complications associated with traditional surgical banding.
Why it matters
Potential benefit: If successful, the device could reduce the need for open-heart surgery in newborns and improve early growth and stability for babies with HLHS.
How similar studies have gone: Early, hand-made percutaneous attempts show promise but have technical limitations that this project aims to overcome.
Where this research is happening
-
Starlight Cardiovascular, INC.
San Diego, United States Active
Researchers
- Principal investigator: Tang, Beverly — Starlight Cardiovascular, INC.
- Study coordinator: Tang, Beverly
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.