ABSTRACT
The AbioCore Total Implantable Replacement Heart (Fig. 1) has been developed by ABIOMED, Inc. (Danvers, Massachusetts, U.S.A.) over the past twenty years. Initial
preclinical trials were conducted at the Texas Heart Institute under the direction
Dr. O. H. Frazier (1). Additional work at the University of Louisville involving the
implantation of all components of the device demonstrated consistent survival in the
bovine model. Approval for a multi-center trial for the use of the AbioCor in humans was
granted by the FDA in early 2001 (2). On July 2, 2001, the device was implanted for the
first time in Robert Tools. This marked the first time that a total implantable system had
been used in a human to provide complete support for the circulation.
