Press Announcements > FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

Press Announcements > FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

FDA expands the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it 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, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The Master Series Mechanical Heart Valve is a rotatable, bileaflet (two-leaflet) valve designed for implantation in the aortic or mitral position. The bileaflet design consists of two semi-circular discs that open and close in response to blood pressure changes during the heartbeat, similar to a patient’s own valve.

The Masters Series Mechanical Heart Valve was first approved in 1995 for patients with a diseased, damaged or malfunctioning aortic or mitral heart valve. The device is also approved for use in replacing previously implanted aortic or mitral prosthetic heart valves. Today’s approval expands the range of valve sizes available, providing smaller patients another treatment option (continue reading FDA Press Announcement from March 6, 2018).
 

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration