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Abbott has obtained clearance from the U.S. Food and Drug Administration (FDA) as well as CE Mark approval for its Amplatzer Piccolo Delivery System, which is used in conjunction with the Amplatzer Piccolo Occluder. This newly approved delivery system has been purpose-built to treat premature infants, some weighing as little as two pounds, who have a heart condition known as patent ductus arteriosus (PDA).

PDA is a condition in which an opening between two major blood vessels in an infant’s heart does not close properly after birth. Prior to birth, this opening is essential, allowing blood to bypass the lungs while the fetus receives oxygen from the mother. However, if the opening remains after birth, it alters normal blood flow by sending excess blood to the lungs, which can interfere with an infant’s ability to breathe effectively.

“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, California. “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.”

The Amplatzer Piccolo Occluder, smaller than a pea, is the world’s first and only minimally invasive, transcatheter therapy approved for closing a PDA in premature infants with this common congenital heart defect. The device is delivered through a small incision in the infant’s leg and guided through the blood vessels to the heart using the Amplatzer Piccolo Delivery System, where it is positioned to close the opening. The Amplatzer Piccolo Occluder received FDA approval and CE Mark certification in 2019.

“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.”

In addition to the Piccolo system, Abbott’s pediatric heart portfolio includes the world’s smallest mechanical heart valve, the Masters HP 15mm, as well as the HeartMate 3 heart pump, which is approved for pediatric use. Abbott remains focused on developing life-saving pediatric devices that deliver immediate clinical impact, provide long-term benefits, reduce the risk of serious complications, and enable physicians to confidently care for the smallest and most vulnerable patients.