(Adds details on valve, doctor comments, background)
March 6 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Abbott Laboratories’ mechanical heart valve to include a size small enough to be used in newborn children.
The FDA said the 15 mm version of Abbott’s Masters HP series valve was the smallest mechanical valve approved in the world.
Traditionally, larger valves meant for adults are used in pediatric patients, but may lead to complications.
“It’s like putting a size 10 foot into a size 6 shoe. You can do it but you won’t walk very well,” Jonathan Chen, a doctor associated with the device’s clinical study told Reuters.
Congenital heart defects affect nearly 1 percent of all births in the United States, and one in four babies have a defect that may require surgery in the first year of birth, according to the company.
Abbott had acquired the Masters HP valve range as part of its $25 billion St. Jude Medical deal. (Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta)