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Abbott's Amplatzer Piccolo™ Delivery System Receives FDA Clearance and CE Mark to Optimize Procedures for Premature Babies With a Hole in the Heart
Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug Administration (FDA) clearance and CE Mark for its Amplatzer Piccolo™ Delivery System, which is used with the company's Amplatzer Piccolo Occluder. The new delivery system is designed specifically to treat premature babies (some weighing as little as two pounds) with a hole in the heart known as a patent ductus arteriosus (PDA).
About this update from Abbott Laboratories
[{"type":"list","items":[{"val":[{"type":"text","content":"First and only delivery system designed specifically for premature infants with a patent ductus arteriosus (PDA), a life-threatening opening in their heart","length":155,"tagName":"p"}]},{"val":[{"type":"text","content":"New delivery system enables precise placement of Abbott's Amplatzer Piccolo Occluder in the tiniest babies","length":110,"tagName":"p"}]},{"val":[{"type":"text","content":"A PDA requiring treatment is present in approximately 20% of premature infants1","length":79,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":344,"olType":false},{"type":"text","content":"ABBOTT PARK, Ill., Dec. 18, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug Administration (FDA) clearance and CE Mark for its Amplatzer Piccolo™ Delivery System, which is used with the company's Amplatzer Piccolo Occluder. The new delivery system is designed specifically to treat premature babies (some weighing as little as two pounds) with a hole in the heart known as a patent ductus arteriosus (PDA).","length":458,"tagName":"p"},{"type":"text","content":"A PDA is an opening between two blood vessels in an infant's heart that fails to close as it should following birth. Before a baby is born, this channel allows blood to bypass the not-yet-functioning lungs because the fetus gets oxygen-rich blood from the mother. If the hole remains open after birth, it changes the flow pattern so additional blood is directed to the lungs, making it difficult for babies to breathe normally.","length":436,"tagName":"p"},{"type":"text","content":""Abbott's new Amplatzer Piccolo Delivery System is a transformative step forward in how we treat PDA in premature infants," said Evan Zahn, M.D., professor of cardiology and pediatrics and director of the Guerin Family Congenital Heart Program at Cedars-Sinai Medical Center in Los Angeles, Calif. "The new delivery system simplifies the implant procedure because only one catheter is needed instead of multiple, and a shorter and softer design allows for more precise device positioning in these tiny babies. Doctors can treat this group with more confidence, reducing the risk of adverse events and improving the long-term outlook for this uniquely vulnerable patient population."","length":706,"tagName":"p"...