Novel Neonatal Ductal Stent Offers a Minimally Invasive Alternative for Critical Congenital Heart Disease
Cincinnati Children’s has treated the first infant in the world using the Lifeline™ Ductus Arteriosus Stent System, a device developed by Starlight Cardiovascular, specifically engineered for neonatal ductal anatomy. The procedure, performed in January as part of an FDA Investigational Device Exemption (IDE) clinical trial, marks a significant advance in catheter-based options for newborns requiring ductal patency for survival.
A Purpose Built Solution for Complex Ductal Anatomy
The inaugural implantation was performed by Shabana Shahanavaz, MD, pediatric interventional cardiologist and director of the Cardiac Catheterization Laboratory at Cincinnati Children’s. The patient, an 8-day-old with double inlet left ventricle and pulmonary atresia, required prompt restoration of pulmonary blood flow.
The Lifeline™ stent is designed to maintain patency of the ductus arteriosus—a fetal vessel that typically closes shortly after birth—providing a critical bridge to more definitive surgical or catheter-based interventions. Unlike adult coronary stents historically adapted for neonatal use, this system incorporates flexibility, trackability and sizing specifically suited for highly curved and tortuous neonatal ducts.
Dr. Shahanavaz noted that for more than a decade, clinicians have been forced to improvise with stents designed for adults:
“The Lifeline™ stent is a major step forward—its design, flexibility and precision make it substantially better suited for neonatal ductal anatomy. This first in-human implantation highlights how purpose-built technology can transform care for our smallest patients.”
