Abbott has received European approvals for two devices designed for children and infants with life-threatening heart defects—including the world’s smallest mechanical heart valve and a separate implant designed for the tiniest babies.
The Masters HP rotatable heart valve—at 15 mm wide, or about the size of a dime—is designed for newborns, infants and toddlers in need of a mitral or aortic valve replacement. The devicemaker’s Masters line of products also includes bileaflet valves sized up to 27 mm.
Meanwhile, the Amplatzer Piccolo Occluder was developed to treat patent ductus arteriosus, one of the most common congenital heart defects in premature babies, which occurs when an opening between two blood vessels leading from the heart fails to close during normal development.
The pea-sized mesh implant expands to seal the opening after being delivered through a minimally invasive procedure and has been approved in newborns as little as under one kilogram.
Abbott estimates that congenital heart defects affect about 36,000 births in the EU annually, with patent ductus arteriosus accounting for up to 10% of all cases. The two newly CE marked devices were previously approved in the U.S.
"While the children who benefit from these therapies represent a very small segment of the total population with structural heart disease, these advanced technologies enable physicians to treat vulnerable pediatric patients who otherwise have limited options," Michael Dale, Abbott's vice president for its structural heart business, said in a statement.