Abbott’s new delivery system for premature babies with heart defects has cleared major regulatory hurdles, giving the tiniest patients access to potentially life-saving treatment. The healthcare giant announced on December 18, 2025, that its Amplatzer Piccolo™ Delivery System received both U.S. Food and Drug Administration clearance and CE Mark approval.
The innovative system is designed specifically for premature infants weighing as little as two pounds who suffer from patent ductus arteriosus (PDA) – commonly described as a hole in the heart. This condition can create serious complications for already vulnerable preemies, and the new delivery system aims to make treatment safer and more effective.
A Small Solution for the Smallest Patients
What makes this development significant? The Amplatzer Piccolo Delivery System simplifies what was once a complex procedure, using a single-catheter technique with a shorter, softer design for more precise positioning during treatment. This innovation reduces potential adverse events – critical when working with such fragile patients.
The system works in conjunction with Abbott’s Amplatzer Piccolo Occluder, a tiny self-expanding wire mesh device smaller than a pea that was approved by the FDA in January 2019. That earlier device has already treated over 3,000 premature babies with PDA, according to company data.
“Abbott’s new Amplatzer Piccolo Delivery System is a transformative step forward in how we treat PDA in premature infants,” said Evan Zahn, M.D., professor of cardiology and pediatrics and director of the Guerin Family Congenital Heart Program at Cedars-Sinai Medical Center in Los Angeles. The device’s design allows for more precise placement in extremely small blood vessels – a delicate procedure that leaves little room for error.
The original Amplatzer Piccolo Occluder remains the only FDA-approved minimally invasive PDA closure device for premature infants, according to Abbott. Its Instructions for Use were updated in July 2020 under PMA supplement S062, but this new delivery system represents a significant advancement in the technology.
Designed with Physician Input
The development process wasn’t conducted in isolation. Sandra Lesenfants, senior vice president of Abbott’s structural heart business, emphasized the collaborative approach: “We designed the Amplatzer Piccolo Delivery System based on feedback from leading physicians across the world to make PDA closure procedures even safer and easier.”
That physician-guided design process reflects a growing trend in medical device development – bringing end users directly into the innovation cycle. For procedures involving premature infants, where margins for error are exceptionally small, such collaboration can be crucial.
The technology represents the culmination of years of engineering work. Developing a catheter-delivered device for babies weighing as little as two pounds presented unique challenges in materials, flexibility, and miniaturization. The device needed to be small enough to navigate tiny blood vessels while still being effective at closing the PDA.
With the simultaneous FDA clearance and CE Mark, the system will become available in both U.S. and European markets. The double regulatory achievement, confirmed by multiple sources, suggests the technology met rigorous safety and efficacy standards across different regulatory frameworks.
The timing couldn’t be better. As neonatal intensive care units continue to improve survival rates for ever-smaller premature infants, the need for specialized medical devices scaled to their unique requirements has grown. Abbott’s new system addresses a critical gap in treatment options for these vulnerable patients.
For parents of premature infants with PDA, this advancement offers something perhaps even more valuable than medical innovation – hope that their child’s heart condition can be addressed with less risk and greater precision than ever before.
