Lifeline—Pediatric Arterial Catheter Stents
（https://www.prnewswire.com/news-releases/starlight-cardiovascular-announces-first-baby-in-the-world-treated-with-lifeline-stent-system-at-cincinnati-childrens-hospital-302720251.html?tc=eml_cleartime）
Product Status: World’s First Human Implantation: The world’s first neonatal implantation was completed at Cincinnati Children’s Hospital in 2026.
FDA Status: Currently in the IDE clinical trial phase (investigative new drug), with plans to recruit 35 patients and expected completion in April 2028.
Target Path: Intending to pursue Humanitarian Device Exemption and Breakthrough Device Designation for accelerated approval.
Design Features (Specifically Designed for Pediatric Arterial Catheters):
Precise Size and Microcatheter System: Matches neonatal arterial catheters (only a few millimeters in diameter), and includes a neonatal-specific microcatheter, solving the problems of adult catheters being too large and difficult to manipulate.
Ultimate flexibility: The nickel-titanium alloy structure allows for 360° tortuosity/ring arterial catheterization, avoiding the problems of stiff adult stents and inability to pass through complex anatomy.
End-to-end full coverage: Completely covers the entire length of the ductus arteriosus with no proximal/distal protrusion, avoiding damage to the aorta/pulmonary artery.
Precise Positioning: Clear imaging markers, controllable release, reduced risk of displacement and re-intervention.
Self-Expansion Design: Adapts to neonatal vascular growth, reducing the need for secondary expansion.
Clinical Advantages (Comparison with Adult Stents/Open-Chest Surgery)
Minimally Invasive Alternative to Open-Chest Surgery: Avoids neonatal cardiopulmonary bypass open-chest surgery (traditional surgery mortality rate 7.2%, complication rate 13.1%), significantly reducing trauma and risk.
Addressing Pain Points of Adult Stents:
—Adult stent re-intervention rate is as high as 47% (size/flexibility mismatch)
—Lifeline conforms to neonatal anatomy, significantly improving permeability, wall apposition, and stability.
Indication Coverage: Applicable to ductus arteriosus-dependent congenital heart disease (such as pulmonary atresia/stenosis, hypoplastic left heart syndrome).
Improved Prognosis: Reduces reoperation, shortens hospital stays, and reduces the burden of neonatal intensive care.
