TUESDAY, March 6, 2018 -- The U.S. Food and Drug Administration has approved the world's smallest mechanical heart valve, designed to be used in newborns and other younger infants with heart defects.
In a news release Tuesday, the agency said it approved a 15 mm version of the Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff.
"While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves," said Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.
More than 35,000 babies in the United States are born each year with heart defects, the agency said, many of them involving defective valves.
The Masters Series Mechanical Heart Valve was first approved in 1995 for people with diseased, damaged or malfunctioning aortic or mitral heart valves. Approval of the smaller size valve was based on a clinical study of 20 infants ranging in age from 1.5 weeks to 27 months.
Potential adverse reactions could include blood clots in the device and bleeding in the brain. The valve should not be used in patients who cannot tolerate anti-clotting drugs, the FDA said.
The product is made by St. Jude Medical, St. Paul, Minn.
The FDA has more about this approval.
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