Abbott Laboratories announced that its Amplatzer Piccolo Delivery System has received U.S. Food and Drug Administration clearance and a CE Mark, a regulatory milestone that enables the device to be sold in the United States and across the European Union.
The delivery system is designed to work with Abbott’s existing Amplatzer Piccolo Occluder, the world’s first minimally invasive transcatheter device for closing patent ductus arteriosus (PDA) in premature infants as small as two pounds. The new system uses a single, shorter, and softer catheter, allowing clinicians to position the occluder more precisely and reducing procedural risk in the tiny hearts of neonates.
By adding the delivery system to its product line, Abbott broadens its pediatric structural‑heart portfolio and strengthens its position in the niche market for congenital heart defect treatment in neonates. The CE Mark opens the device to the European market, where demand for PDA closure is high and competition is limited, potentially adding a new high‑growth revenue stream to Abbott’s medical‑device segment.
"We designed the Amplatzer Piccolo Delivery System based on feedback from leading physicians worldwide to make PDA closure procedures even safer and easier," said Sandra Lesenfants, Senior Vice President of Abbott’s structural heart business. Dr. Evan Zahn, Professor of Cardiology and Pediatrics at Cedars‑Sinai, added, "The new delivery system simplifies the implant procedure because only one catheter is needed, and a shorter, softer design allows for more precise device positioning in these tiny babies, giving doctors more confidence and improving long‑term outcomes."
The Piccolo Occluder was first FDA‑approved in 2019, and the delivery system builds on that success by addressing a critical procedural challenge. With the combined product offering, Abbott is positioned to capture a larger share of the neonatal PDA market, which represents a high‑growth, low‑competition segment that can drive future earnings growth in its medical‑device division.
The approval is expected to enhance Abbott’s competitive advantage in pediatric structural heart care, support the company’s broader strategy of innovation in high‑growth, low‑competition markets, and provide a foundation for future revenue expansion in both the U.S. and European markets.
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