Three-year data “reinforce safety and efficacy” of Abbott’s Amplatzer Piccolo in infants with PDA

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Abbott has announced three-year data for its Amplatzer Piccolo occluder for the treatment of patent ductus arteriosus (PDA) in infants. 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, Abbott said in a press release.

The data were presented at the Pediatric and Congenital Interventional Cardiovascular Society (PICS) 2022 Symposium (7‒10 September, Chicago, USA).

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 foetus 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.

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 a high survival rate (95.5%), with no procedure-related deaths; a high implant success rate (95.5%) and complete PDA closure in nearly all patients, and a low device-related serious adverse event rate (2%) with no late (>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, Abbott’s press release adds. 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 (Smidt Heart Institute and Department of Pediatrics at Cedars-Sinai Medical Center, Los Angeles, USA), 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.”


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