Abbott’s Amplatzer Piccolo Delivery System granted FDA and CE clearance

Abbott (ABT) has received FDA clearance and CE Mark for its Amplatzer Piccolo Delivery System, which is used with the company’s Amplatzer Piccolo Occluder. The new delivery system is designed specifically to treat premature babies with a hole in the heart known as a patent ductus arteriosus, or PDA. A PDA is an opening between two blood vessels in an infant’s heart that fails to close as it should following birth. Before a baby is born, this channel allows blood to bypass the not-yet-functioning lungs because the fetus gets oxygen-rich blood from the mother. If the hole remains open after birth, it changes the flow pattern so additional blood is directed to the lungs, making it difficult for babies to breathe normally. The Amplatzer Piccolo Occluder received FDA approval and CE Mark in 2019.