FDA approves smallest valve for babies with congenital heart defects

The FDA has approved the smallest mechanical heart valve yet, Abbott’s 15-millimeter Masters HP valve, which can be used to treat babies and toddlers in need of mitral or aortic valve replacement.

The dime-sized valve is designed for newborns and infants, some of whom can’t be treated with larger valve sizes, according to a March 6 Abbott press release.

"In my practice, I want to be able to provide a treatment option that works for a critically ill child when a larger-sized valve may not be suitable,” Kirk R. Kanter, MD, professor of surgery and director of the Heart Transplant Program at Children's Healthcare in Atlanta at Emory University School of Medicine, said in the release. Kanter’s center was the top enrolling site for the clinical trial which led to the FDA approval of the valve.

"The approval of this smaller pediatric mechanical heart valve provides surgeons with a much-needed option for treating these vulnerable, high-risk children."

Congenital heart defects affect nearly 1 percent of births in the U.S., about 40,000 each year, according to the Centers for Disease Control and Prevention. Replacing a damaged valve allows blood to flow properly through the heart.

Abbott’s Masters Series line of heart valves now contains seven diameter sizes ranging from 15 to 27 mm.