The agency greenlighted a 15 millimeter version of Abbott Laboratories’ Masters Series Mechanical Heart Valve. The valve contains two semicircular disks that open and close in response to blood pressure changes and is intended for implantation in the aortic or mitral position.
The 15 mm device is now the smallest mechanical heart valve approved in the world.
“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 Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
Editor’s note: This article was updated March 13.
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