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FDA Expands Approval Of Replacement Heart Valve

The U.S. Food and Drug Administration expanded 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 or HP Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world. The FDA granted approval of the Master Series Heart Valve to St. Jude Medical.

The FDA warned that the Master Series Mechanical Heart Valve should not be used by patients unable to tolerate anticoagulation therapy.

Heart valve disease occurs if one or more of the four heart valves, which direct the flow of blood through the heart, fail to function properly. In pediatric patients, a malfunctioning heart valve is often the result of a congenital heart defect at birth.

Each year, more than 35,000 babies in the U.S. are born with congenital heart defects, some of which will require heart valve surgery and, potentially, replacement heart valve surgery. However, prior to today's approval, there have been limited replacement heart valve options available because of the patients' small size. The Masters Series 15-mm HP valve represents an important treatment option for these patients.

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.

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