Additionally, the system picked up CE mark for commercialization in Europe.
The company designed its new delivery system specifically to treat premature babies — some weighing as little as 2 lb — with a hole in the heart known as a patent ductus arteriosus (PDA). A PDA is an opening between two blood vessels in an infant’s heart that fails to close as it should following birth.
If this hole remains after birth, it changes the flow pattern, directing additional blood to the lungs. This makes it difficult for babies to breathe normally.
The new delivery system optimizes implantation procedures with the company’s Amplatzer Piccolo Occluder, the world’s smallest heart device to treat premature babies with PDA.
“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, Calif. “The new delivery system simplifies the implant procedure because only one catheter is needed instead of multiple, and a shorter and softer design allows for more precise device positioning in these tiny babies. Doctors can treat this group with more confidence, reducing the risk of adverse events and improving the long-term outlook for this uniquely vulnerable patient population.”
More about the Abbott Amplatzer Piccolo Occluder and delivery system
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.
Abbott says its portfolio of pediatric heart therapies also includes the world’s smallest mechanical heart valve, the Masters HP 15mm. It also features the HeartMate 3 heart pump, which has approval for pediatric patients.
The company said it plans to continue to develop life-saving pediatric devices that have an immediate impact with long-term benefits. It hopes to reduce the risks of life-threatening complications and allow physicians to confidently treat the youngest, smallest patients.
“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,” said Sandra Lesenfants, SVP of Abbott’s structural heart business. “With the Amplatzer Piccolo Occluder, which is the world’s smallest heart device, and now with the new delivery system to complement it, we’re continuing to advance how we meet the needs of our tiniest patients with structural heart disease.”
