FDA clears Abbott's heart valve device, the world's smallest

human heart
The FDA has cleared the world’s smallest heart valve device made by Abbot for use in infants and toddlers.

The FDA approved Abbott’s Masters HP 15mm device, which is the world’s smallest mechanical heart valve that will allow surgeons to treat infants and children who need mitral or aortic valve replacement.

The device, which was initially developed by St. Jude Medical before it was acquired by Abbott, is about the size of a dime and is the first and only pediatric mechanical heart valve designed for newborns and infants, according to Abbott.

"There's an urgent need for the smallest babies and children who need a suitable replacement valve in order to survive," Michael Dale, an Abbott vice president, said in a statement. "Abbott's new mechanical pediatric heart valve is a life-changing technology for the smallest pediatric patients, giving them a better chance at a long, healthy life with a fully functioning heart."

First approved by the regulatory agency in 1995, the valve features pyrolytic carbon leaflets and orifice rings, an 85-degree leaflet opening angle for improved flow and reduced turbulence, and a controlled torque rotation mechanism. There is also a sewing cuff with additional suture markers allowing for improved placement.

Congenital heart defects affect about 1% or 40,000 newborns in the U.S. each year, according to the Centers for Disease Control.