- Abbott announced Monday it received FDA approval for a device designed to seal an opening in the heart of premature infants called patent ductus arteriosus, or PDA, that sometimes fails to close naturally after birth.
- The self-expanding wire mesh device, called the Amplatzer Piccolo Occluder, is described as being smaller than a small pea, is implanted in a minimally invasive procedure and can treat babies weighing as little as 2 pounds.
- Abbott's U.S. pivotal trial, ADO II AS, which studied 50 patients with a PDA who were older than three days, supported FDA approval of the device. The safety and efficacy of the device were further evaluated under a continued access protocol involving an additional 150 patients, the company said.
Every baby is born with a ductus arteriosus, which is a hole that allows blood to detour away from the lungs before birth. It is no longer needed after birth and typically closes in a few days.
Failure of the ductus to close can cause increased blood flow to the lungs, making it difficult for the babies to breathe. Most children can have the PDA closed in a procedure in which a coil or other device is inserted through a catheter into the blood vessels to reach and plug the hole, according to the American Heart Association (AHA).
In premature newborns, failure of the ductus to close is common. Medicine is often effective in helping the ductus to close in these babies but doesn't work as well after the first few weeks of life, the AHA said.
About 60,000 premature babies in the United States are born each year with very low birth weight, and about one-fifth have a PDA that is large and requires urgent treatment, according to Abbott. The Amplatzer Piccolo Occluder is the first minimally invasive, transcatheter device approved specifically for premature babies with a PDA, Abbott said.
"This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive," said Evan Zahn, director of the Congenital Heart Program at Cedars-Sinai's Smidt Heart Institute and principal investigator for Abbott's study.
Abbott also makes the Amplatzer Duct Occluder II device to treat PDA in larger-size pediatric patients.