Three-year data on the Amplatzer Piccolo Occluder the world's smallest heart device to treat patent ductus arteriosus
Abbott announced three-year data showing the positive impact of the Amplatzer Piccolo Occluder on treating babies (some weighing as little as two pounds) with a potentially life-threatening hole in the heart known as a patent ductus arteriosus (PDA)
The Amplatzer Piccolo device is smaller than a pea and is the world's first and only minimally invasive, transcatheter treatment approved to close a PDA in premature infants with this common congenital heart defect. The latest data were presented at the Pediatric and Congenital Interventional Cardiovascular Society Symposium, held in Chicago from September 7-10, 2022.
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. Prior to the development of Abbott's minimally invasive Piccolo closure device, physicians and families often had to decide between placing a baby on respiratory support to see if the defect sealed on its own or conducting a risky surgical procedure to close the PDA.
Three-Year Results from the Amplatzer Piccolo Study: The ADO II AS trial showed the safety and effectiveness of the Amplatzer Piccolo device in closing PDAs in premature babies, with data through three years showing: i. High survival rate (95.5%), with no procedure-related deaths. ii. High implant success rate (95.5%) and complete PDA closure in nearly all patients. iii. Low device-related serious adverse event rate (2%) with no late (greater than 1 year) device-related events.
The data confirm that the Amplatzer Piccolo Occluder can offer high success rates in terms of PDA closure while offering low adverse event rates. The minimally invasive approach to delivery of the device also reduces the need to subject many of the tiniest patients to riskier surgical procedures.
"The Amplatzer Piccolo Occluder is a lifesaving device for premature infants with PDAs, many of whom require urgent treatment to survive but aren't responding to medical management and are at high risk for surgery," said Evan Zahn, M.D., director of the Guerin Family Congenital Heart Program in the Smidt Heart Institute and Department of Pediatrics at Cedars-Sinai Medical Center, and principal investigator of the ADO II AS trial. "The data from this study reinforce Piccolo's ability to safely and effectively treat this life-threatening heart problem for our tiniest patients."
About the Amplatzer Piccolo Occluder: The Amplatzer Piccolo is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart, where it's placed to seal the PDA. As a minimally invasive procedure, many of the premature babies who are critically ill in the neonatal intensive care unit can be weaned from artificial respirator support soon after the device is implanted.
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