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.