Starlight Cardiovascular has announced that the first baby in the world was treated with its Lifeline Ductus Arteriosus stent system at Cincinnati Children’s Hospital (Cincinnati, USA) in January.
The device is currently being studied under a US Food and Drug Administration Investigational Device Exemption clinical trial.
Shabana Shahanavaz, a paediatric interventional cardiologist and director of the cardiac cath lab at Cincinnati Children’s Hospital, performed the procedure on an eight-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 foetal circulation and closes shortly after birth, open to provide critical pulmonary blood flow.
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 is the most common type of birth defect and affects 1% of all newborns. Babies with certain congenital heart diseases 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 Aimee Armstrong, national principal investigator and director of the cardiac cath lab at Nationwide Children’s Hospital (Columbus, USA).
“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,” said Armstrong. “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.”
