The device treats newborns — some weighing as little as two pounds — with a hole in the heart. The condition, known as patent ductus arteriosus (PDA), is potentially life-threatening. PDA is present in approximately one of 2,000 births, per the Journal of Interventional Cardiology.
Abbott Park, Illinois-based Abbott’s study found low adverse rates following a piccolo procedure. The company said in a news release that it shows the additional benefit of the device that can help babies avoid riskier surgery. Before the introduction of the device, a decision often had to be made between putting a baby on respiratory support to see if the defect sealed on its own or conducting the risky surgical procedure to close the PDA.
The Amplatzer Piccolo is smaller than a pea, the company said. Abbott said it represents the world’s first and only minimally invasive, transcatheter treatment approved to close a PDA in premature infants. The FDA approved the self-expanding, wire mesh device that’s inserted via the aortic or pulmonary artery in 2019.
Positive data for Amplatzer Piccolo
Data were presented at the Pediatric and Congenital Interventional Cardiovascular Society Symposium in Chicago. Results from the ADO II AS trial demonstrated safety and effectiveness for the Amplatzer Piccolo.
The device produced a high survival rate of 95.5% with no procedure-related deaths. Abbott reported a high implant success rate (95.5%) and complete PDA closure in nearly all patients. The study produced a low device-related serious adverse event rate of 2% with no late (post-one year) device-related events.
Abbott said the data proves that Amplatzer Piccolo offers high success rates with low adverse event rates. It also reduces the need to subject newborns to the risky 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 Dr. Evan Zahn, 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.”
More good news in Amplatzer family of products
The news comes one day after Abbott announced a major step forward within the Amplatzer occluder family of devices. The company launched its Amplatzer Talisman patent foramen ovale (PFO) occlusion system in Europe.
PFO is a hole in the heart that doesn’t close following birth. The company designed the Amplatzer Talisman to treat people with PFO who experienced a stroke and are at risk of having another.
