Abbott's Amplatzer Piccolo Delivery System Receives FDA Clearance for Treating Heart Defects in Premature Infants
Key Insights
Abbott has received FDA clearance and CE Mark for its Amplatzer Piccolo Delivery System (search), designed specifically to treat patent ductus arteriosus (search) (PDA (search)) in premature infants weighing as little as two pounds.
The new delivery system simplifies PDA (search) closure procedures by requiring only one catheter instead of multiple, with a shorter and softer design that enables more precise device positioning in tiny babies.
Patent ductus arteriosus (search) affects approximately 20% of premature infants and involves a life-threatening opening between blood vessels in the heart that fails to close after birth.
Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE Mark for its Amplatzer Piccolo Delivery System (search), marking a significant advancement in treating patent ductus arteriosus (search) (PDA (search)) in premature infants. The new delivery system is designed specifically for premature babies, some weighing as little as two pounds, who suffer from this life-threatening heart defect.
Understanding Patent Ductus Arteriosus
Patent ductus arteriosus (search) is an opening between two blood vessels in an infant's heart that fails to close as it should following birth. Before birth, this channel allows blood to bypass the not-yet-functioning lungs because the fetus receives oxygen-rich blood from the mother. When 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. A PDA (search) requiring treatment is present in approximately 20% of premature infants.
Clinical Advantages of the New Delivery System
"Abbott's new Amplatzer Piccolo Delivery System (search) is a transformative step forward in how we treat PDA (search) 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. "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."
The improved design enables doctors to treat this vulnerable patient population with greater confidence, reducing the risk of adverse events and improving long-term outcomes for premature infants with PDA (search).
Device Technology and Procedure
The Amplatzer Piccolo Delivery System (search) works in conjunction with Abbott's Amplatzer Piccolo Occluder (search), which is smaller than a pea and represents the world's first and only minimally invasive, transcatheter treatment approved to close a PDA (search) in premature infants. The Amplatzer Piccolo device is inserted through a small incision in the infant's leg and guided through vessels to the heart using the delivery system, where it is positioned to seal the opening in the heart.
The Amplatzer Piccolo Occluder (search) originally received FDA approval and CE Mark in 2019, establishing the foundation for this minimally invasive approach to treating congenital heart defects in the most vulnerable patients.
Development Based on Clinical Feedback
"We designed the Amplatzer Piccolo Delivery System (search) based on feedback from leading physicians across the world to make PDA (search) closure procedures even safer and easier," said Sandra Lesenfants, senior vice president of Abbott's structural heart business. "With the Amplatzer Piccolo Occluder (search), 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 (search)."
Expanding Pediatric Portfolio
Abbott's commitment to pediatric cardiac care extends beyond the Amplatzer Piccolo system. The company's portfolio of pediatric heart therapies includes the world's smallest mechanical heart valve, the Masters HP 15mm (search), and the HeartMate 3 (search) heart pump, which is approved for pediatric patients. Abbott continues to develop lifesaving pediatric devices that provide immediate impact with long-term benefits, reduce the risks of life-threatening complications, and allow physicians to confidently treat the youngest and tiniest patients.