The AbioCor™ implantable replacement heart is the first completely self-contained total artificial heart. It is the product of 30 years of research, development, and testing conducted by ABIOMED, Inc. and its collaborators, with the support of the National Heart, Lung and Blood Institute. The AbioCor is designed to sustain the body's circulatory system and to extend the lives of patients who would otherwise die of heart failure. Its unique design allows it to be totally implanted within the body. Unlike the artificial hearts of the past, patients are not tethered to a large, air-pumping console nor do they have wires or tubes piercing their skin. The FDA approved the AbioCor for commercial approval under a Humanitarian Device Exemption (HDE) in September 2006.