Abbott’s Amplatzer Piccolo Occluder to Treat PDA in Newborns Evaluated in 3-Year Data From ADO II AS Trial

September 8, 2022—Abbott announced that 3-year data demonstrated the positive impact of treatment with the company’s Amplatzer Piccolo occluder on babies (some weighing as little as two pounds) with a patent ductus arteriosus (PDA).

The transcatheter Amplatzer Piccolo device is approved to close a PDA in premature infants. The Amplatzer Piccolo occluder received FDA approval in January 2019.

The latest data from the ADO II AS trial (“Amplatzer duct occluder in additional sizes”) were presented at PICS, the Pediatric and Congenital Interventional Cardiovascular Society Symposium, held September 7-10, 2022, in Chicago, Illinois.

According to Abbott, the ADO II AS trial showed the safety and effectiveness of the Amplatzer Piccolo device in closing PDAs in premature babies with the following data at 3 years:

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

The company stated that the data confirm that the Amplatzer Piccolo occluder can offer high success rates in terms of PDA closure while offering low adverse event rates and show that the minimally invasive approach to the delivery of the device reduces the need to subject many of the tiniest patients to riskier surgical procedures.

The principal investigator of the ADO II AS trial is Evan Zahn, MD, director of the Guerin Family Congenital Heart Program in the Smidt Heart Institute and Department of Pediatrics at Cedars-Sinai Medical Center in Los Angeles, California.

Dr. Zahn stated in the company’s press release, “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. The data from this study reinforce Piccolo’s ability to safely and effectively treat this life-threatening heart problem for our tiniest patients.”