CardiacAssist, Inc. Receives FFA Sciences IDE Approval for Use of the TandemHeart System in Pivotal Clinical Study

PITTSBURGH--(BUSINESS WIRE)--CardiacAssist, Inc., a privately-held medical technology company headquartered in Pittsburgh, Pennsylvania, announced today that it received Investigational Device Exemption (IDE) approval from the Food & Drug Administration (FDA) for a pivotal clinical study of the TandemHeart circulatory support system. The TandemHeart to Reduce Infarct Size (TRIS) Trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients who have suffered a severe heart attack.