Abbott released three-year data showing the positive impact of its Amplatzer Piccolo occluder to treat babies—some as small as two pounds—with patent ductus arteriosus (PDA), a potentially life-threatening hole in the heart.
 
The latest data was presented at the Pediatric and Congenital Interventional Cardiovascular Society Symposium, held in Chicago from September 7-10, 2022.
 
Amplatzer Piccolo is smaller than a pea and according to the company is the world’s first and only minimally invasive, transcatheter treatment approved to close a PDA in premature infants with the congenital heart defect.
 
Prior to the Piccolo device, physicians and families often had to decide between respiratory support to see if the defect sealed on its own or conduct a risky procedure to close the PDA.
 
The ADO II AS trial showed Piccolo’s safety and effectiveness in closing PDAs in premature babies, with data through three years showing:

• High survival rate (95.5%), with no procedure-related deaths
• High implant success rate (95.5%) and complete PDA closure in nearly all patients
• Low device-related serious adverse event rate (2%) with no late (>1 year) device-related events

 
The data confirms the Amplatzer Piccolo Occluder can offer high success rates for PDA closure with low adverse event rates. The minimally invasive approach 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,” 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 told the press. “The data from this study reinforce Piccolo’s ability to safely and effectively treat this life-threatening heart problem for our tiniest patients.”