Abbott Wins Clearance to Sell Heart Device for Premature Infants

Abbott has received U.S. Food and Drug Administration clearance and a CE mark to sell its Amplatzer Piccolo Delivery System in the United States and European Union, expanding treatment options for premature infants with life-threatening heart conditions.

The delivery system is used to implant Abbott’s Amplatzer Piccolo Occluder, a minimally invasive device designed to close a patent ductus arteriosus (PDA)—an abnormal opening in the heart. PDA is uncommon in full-term infants but affects up to 30% of babies weighing under 2.5 kilograms at birth. The occluder itself was authorized in the U.S. and EU in 2019.

Abbott said physician feedback and years of real-world experience guided the design of the new delivery device, with the goal of making procedures safer and easier. Clinical data from a trial involving 200 infants showed implant success rates above 95%, rising to 99% in the smallest patients.

The clearance strengthens Abbott’s structural heart portfolio, which posted double-digit growth in recent quarters.

22-12-2025