December 22, 2025 (U.S.) – Abbott Receives Clearance for Heart Delivery Device in Premature Babies – Global healthcare technology leader Abbott has announced that it has received both U.S. Food and Drug Administration (FDA) clearance and a CE Mark in the European Union for its Amplatzer Piccolo™ Delivery System, a device designed specifically to support heart procedures in premature infants with a life‑threatening congenital condition known as patent ductus arteriosus (PDA).
Patent ductus arteriosus (PDA) is a condition in which a blood vessel in the heart that is normally open before birth fails to close shortly after, causing abnormal blood flow and increased strain on the infant’s lungs and heart. This condition is relatively common in premature babies and often requires medical intervention.
The newly cleared delivery system is intended for use with Abbott’s Amplatzer Piccolo Occluder, a pea‑sized device already approved to close PDA in the tiniest patients. By enabling more precise placement of the occluder, the Piccolo Delivery System is designed to make PDA closure procedures safer and easier for clinicians treating the most vulnerable infants.
“We designed the Amplatzer Piccolo Delivery System based on feedback from leading physicians across the world to make PDA closure procedures even safer and easier,” said Sandra Lesenfants, senior vice president of Abbott’s structural heart business.
Key Highlights of Abbott’s Piccolo Delivery System Clearance
- FDA clearance and CE Mark secured for the Amplatzer Piccolo Delivery System for use in premature infants with PDA.
- Designed to work with the Amplatzer Piccolo Occluder, the first‑of‑its‑kind transcatheter device for this patient population.
- System aims to simplify procedures by improving precision and reducing procedural complexity.
- Intended for use in infants weighing as little as about two pounds (approximately 900 grams).
- Represents a significant advancement in minimally invasive cardiac care for premature babies with congenital heart defects.
Industry experts note that this regulatory milestone not only enhances Abbott’s structural heart portfolio but also underscores the company’s ongoing commitment to innovative solutions for pediatric heart conditions. The Piccolo Delivery System’s clearance allows clinicians in both the United States and Europe to adopt a purpose‑built tool aimed at improving outcomes for some of the smallest and most fragile patients in neonatal care.
