FDA clears Abbott delivery device for closing holes in the hearts of premature infants
Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval for its Amplatzer Piccolo Delivery System. The device was developed for clinicians to use when implanting the company’s Amplatzer Piccolo Occluder in a premature baby with a patent ductus arteriosus (PDA).
PDAs are holes between two blood vessels that typically close when a baby is born. In rare instances, however, the hole stays open after birth, directing too much blood toward the lungs and impacting the neonate’s ability to breathe.
The Amplatzer Piccolo Occluder first secured FDA approval and CE mark approval in 2019. It is the first transcatheter treatment to gain FDA clearance for closing a PDA in a premature infant. The device is smaller than a pea and delivered through a tiny incision in the child’s leg before it is guided to the heart using the newly cleared Amplatzer Piccolo Delivery System.
“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,” Sandra Lesenfants, senior vice president of Abbott's structural heart business, said in a prepared statement. “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.”
“Abbott's new Amplatzer Piccolo Delivery System is a transformative step forward in how we treat PDA in premature infants,” added Evan Zahn, MD, professor of cardiology and pediatrics and director of the Guerin Family Congenital Heart Program at Cedars-Sinai Medical Center. “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.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.