R44HL158304
Project Grant
Overview
Grant Description
Ductus Arteriosus Stent to Improve Congenital Heart Defect Mortality - 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 13.1% risk of morbidity and 7.2% 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.
The feasibility of the innovative stent system designed for pediatric applications using self-expanding technology was demonstrated in a successful Phase I through numerous rounds of bench testing, physician evaluations, and an animal study. This Phase II application proposes finalizing the stent design and completing preclinical testing necessary for a clinical trial and FDA approval.
Through rapid iterations, Starlight will begin by optimizing the stent system for design characteristics and manufacturability. Starlight will then complete a chronic GLP animal study in 16 newborn lambs to demonstrate stent patency over 180 days.
Verification and validation (V&V) testing of all aspects of the stent system (including biocompatibility, sterilization, and mechanical testing) will then be performed in accordance with FDA guidance documents for endovascular stents.
This Phase II project will result in a finalized ductus arteriosus stent system design that has passed all of the necessary preclinical testing required for a clinical trial and subsequent FDA approval through the Humanitarian Device Exemption pathway.
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 13.1% risk of morbidity and 7.2% 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.
The feasibility of the innovative stent system designed for pediatric applications using self-expanding technology was demonstrated in a successful Phase I through numerous rounds of bench testing, physician evaluations, and an animal study. This Phase II application proposes finalizing the stent design and completing preclinical testing necessary for a clinical trial and FDA approval.
Through rapid iterations, Starlight will begin by optimizing the stent system for design characteristics and manufacturability. Starlight will then complete a chronic GLP animal study in 16 newborn lambs to demonstrate stent patency over 180 days.
Verification and validation (V&V) testing of all aspects of the stent system (including biocompatibility, sterilization, and mechanical testing) will then be performed in accordance with FDA guidance documents for endovascular stents.
This Phase II project will result in a finalized ductus arteriosus stent system design that has passed all of the necessary preclinical testing required for a clinical trial and subsequent FDA approval through the Humanitarian Device Exemption pathway.
Awardee
Funding Goals
TO FOSTER HEART AND VASCULAR RESEARCH IN THE BASIC, TRANSLATIONAL, CLINICAL AND POPULATION SCIENCES, AND TO FOSTER TRAINING TO BUILD TALENTED YOUNG INVESTIGATORS IN THESE AREAS, FUNDED THROUGH COMPETITIVE RESEARCH TRAINING GRANTS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
California
United States
Geographic Scope
State-Wide
Analysis Notes
Amendment Since initial award the End Date has been extended from 07/31/24 to 12/31/27 and the total obligations have increased 151% from $1,256,635 to $3,158,101.
Starlight Cardiovascular was awarded
Ductus Arteriosus Stent for Congenital Heart Defects
Project Grant R44HL158304
worth $3,158,101
from National Heart Lung and Blood Institute in August 2021 with work to be completed primarily in California United States.
The grant
has a duration of 6 years 4 months and
was awarded through assistance program 93.837 Cardiovascular Diseases Research.
The Project Grant was awarded through grant opportunity NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional).
SBIR Details
Research Type
SBIR Phase II
Title
DUCTUS ARTERIOSUS STENT TO IMPROVE CONGENITAL HEART DEFECT MORTALITY
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 13.1% risk of morbidity and 7.2% 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. The feasibility of the innovative stent system designed for pediatric applications using self-expanding technology was demonstrated in a successful Phase I through numerous rounds of bench testing, physician evaluations, and an animal study; and this Phase II application proposes finalizing the stent design and completing preclinical testing necessary for a clinical trial and FDA approval. Through rapid iterations, Starlight will begin by optimizing the stent system for design characteristics and manufacturability. Starlight will then complete a chronic GLP animal study in 16 newborn lambs to demonstrate stent patency over 180 days. Verification and validation (VandV) testing of all aspects of the stent system (including biocompatibility, sterilization, and mechanical testing) will then be performed in accordance with FDA guidance documents for endovascular stents. This Phase II project will result in a finalized ductus arteriosus stent system design that has passed all of the necessary preclinical testing required for a clinical trial and subsequent FDA approval through the Humanitarian Device Exemption pathway.
Topic Code
NHLBI
Solicitation Number
PA21-259
Status
(Ongoing)
Last Modified 9/24/25
Period of Performance
8/6/21
Start Date
12/31/27
End Date
Funding Split
$3.2M
Federal Obligation
$0.0
Non-Federal Obligation
$3.2M
Total Obligated
Activity Timeline
Transaction History
Modifications to R44HL158304
Additional Detail
Award ID FAIN
R44HL158304
SAI Number
R44HL158304-2806046831
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Small Business
Awarding Office
75NH00 NIH National Heart, Lung, and Blood Institute
Funding Office
75NH00 NIH National Heart, Lung, and Blood Institute
Awardee UEI
W3TSK3T9QHJ7
Awardee CAGE
8NXF0
Performance District
CA-90
Senators
Dianne Feinstein
Alejandro Padilla
Alejandro Padilla
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Heart, Lung, and Blood Institute, National Institutes of Health, Health and Human Services (075-0872) | Health research and training | Grants, subsidies, and contributions (41.0) | $2,158,183 | 100% |
Modified: 9/24/25