Abbott Laboratories said the U.S. Food and Drug Administration approved its heart implant to treat premature babies with a certain heart disease.
Patent ductus arteriosus, or PDA, is a potentially life-threatening condition characterized by an opening between two blood vessels leading from the heart. The opening, used by the fetus to receive oxygen-rich blood from the mother, usually seals itself after the birth. In some babies, the pathway does not close, making it difficult for them to breathe normally due to increased blood flow to the lungs.
The company said Amplatzer Piccolo Occluder is the world's first medical device that can be implanted in the tiniest babies without surgery to treat PDA. The device is inserted through a small incision in the leg and guided through vessels to the heart, where it seals the opening.
The approval is based on a study called ADO II AS in 50 babies who were older than three days. The application also used data from 150 more infants who were treated with the device under the FDA's continued access protocol, which allows doctors to access a medical device while its application is under review.
The Abbott Park, Ill.-based company said about 60,000 premature babies are born in the U.S. each year with very low birth weight, and nearly 12,000 of them have a PDA that requires treatment.