Abbott’s Amplatzer Piccolo Delivery System Earns FDA, EU Nods

Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark for its Amplatzer Piccolo delivery system used with its Amplatzer Piccolo occluder. The new delivery system was designed to treat premature babies—some weighing as little as two pounds—with a hole in the heart known as a patent ductus arteriosus (PDA).

A PDA is an opening between two blood vessels in an infant’s heart that fails to close as it should after 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 stays open following birth, it changes the flow pattern so additional blood is directed to the lungs, making it difficult for babies to breathe normally.

The Amplatzer Piccolo occluder is smaller than a pea and according to Abbott is the world’s first and only minimally invasive, transcatheter treatment approved to close a PDA in premature infants with the common congenital heart defect. The device is inserted through a small incision in the infant’s leg and guided through the vessels using the Amplatzer Piccolo delivery system, where it’s placed to seal the opening in the heart.

The Amplatzer Piccolo occluder received FDA approval and CE mark in 2019.

“Abbott’s new Amplatzer Piccolo Delivery System is a transformative step forward in how we treat PDA in premature infants,” said Evan Zahn, MD, 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.”

“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. “With the Amplatzer Piccolo Occluder, which is the world’s smallest heart device, and now with the new delivery system to complement it, we’re continuing to advance how we meet the needs of our tiniest patients with structural heart disease.”