Abbott’s Amplatzer Piccolo Delivery System Approved to Treat PDA in Premature Babies

December 18, 2025—Abbott announced it has received FDA clearance and CE Mark approval for its Amplatzer Piccolo delivery system, which is used with the company’s Amplatzer Piccolo occluder.

According to Abbott, the new delivery system is designed specifically to treat premature babies (some weighing as little as 2 pounds) with a patent ductus arteriosus (PDA). The Amplatzer Piccolo delivery system is used to guide the transcatheter occluder through an infant’s vessels to the heart, where the occluded is placed to seal the opening in the heart. The occluder received FDA approval and CE Mark approval in 2019, noted the company.

Evan Zahn, MD, who is Professor of Cardiology and Pediatrics and Director of the Guerin Family Congenital Heart Program at Cedars-Sinai Medical Center in Los Angeles, California, commented on the device in the company’s press release.

“Abbott’s new Amplatzer Piccolo delivery system is a transformative step forward in how we treat PDA in premature infants,” stated Dr. Zahn. “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.”