The U.S. Food and Drug Administration (FDA) has issued a safety communication warning of serious adverse events associated with two implantable left ventricular assist devices. The two heart systems, which happen to be the only implantable devices of their kind approved by the FDA, are the HeartMate II Left Ventricular Assist System, manufactured by Thoratec Corporation, and the HeartWare Ventricular Assist System, manufactured by HeartWare, Inc.
According ...
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