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Abbott wins US FDA approval for smallest mechanical heart valve

The U.S. Food and Drug Administration approved an Abbott Laboratories mechanical heart valve in a size small enough to be used in newborn children to treat heart defects.

The agency approved the 15-millimeter size of the Masters Series mechanical heart valves with Hemodynamic Plus sewing cuff, making it the smallest mechanical heart valve approved in the world.

Heart valve disease occurs when one or more of the four heart valves, which direct the flow of blood through the heart, fail to function properly. In children, a malfunctioning heart valve is usually the result of a congenital heart defect at birth. A congenital heart defect is a problem with the structure of the heart.

Before the current approval, there have been limited replacement heart valve options available because of the patients' small size.

The company acquired the valve range as part of its $25 billion deal with St. Jude Medical Inc.