Starlight Cardiovascular Announces First Baby Treated with Lifeline Stent System

Starlight Cardiovascular announced that the first baby in the world was treated with its Lifeline Ductus Arteriosus Stent System at Cincinnati Children's Hospital in January. The device is currently being studied under a U.S. Food and Drug Administration Investigational New Drug clinical trial.

Dr. Shabana Shahanavaz, a pediatric interventional cardiologist and Director of the Cardiac Catheterisation Laboratory at Cincinnati Children's Hospital, performed the procedure on an 8-day-old baby with Double Inlet Left Ventricle and Pulmonary Atresia, a complex congenital heart defect that results in inadequate blood flow to the baby's lungs. Starlight's Lifeline Stent is designed to keep the ductus arteriosus, a vessel that exists in the fetal circulation and closes shortly after birth, open to provide critical pulmonary blood flow.

Dr. Shahanavaz stated, "In my 15 years of practice, we have adapted adult-designed stents to treat newborns because no dedicated alternative existed. 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. We are especially excited and proud to be the first site to implant this novel stent, underscoring our commitment to advancing innovation and bringing the latest, most thoughtfully designed technologies to the patients who need them most."

Congenital Heart Disease (CHD) is the most common type of birth defect and affects 1 per cent of all newborns. Babies with certain CHDs require immediate intervention to survive, and oftentimes this involves an open-chest surgery. The Lifeline Ductus Arteriosus Stent System provides a minimally invasive alternative to a major surgery on a newborn.

The clinical trial is led by Dr. Aimee Armstrong, National Principal Investigator and Director of the Cardiac Catheterisation Laboratory at Nationwide Children's Hospital. Dr. Armstrong stated, "Up until the availability of the Lifeline stent in this trial, babies needing an open ductus for blood flow to the lungs have either been getting a high-risk surgery or a ductal stent approved only for adult heart disease. These adult stents are stiff and not made for highly curvy ducts. The Lifeline stent is purpose-built for ducts, which turn and bend, sometimes in a 360-degree configuration. We are so happy to start using the Lifeline stent in this trial, as it has the potential to be much safer and easier to use than the current adult stents."