Abiomed, Inc., has asked the Food and Drug Administration if it can begin testing an implantable replacement heart in humans.
Abiomed said on December 22 that it had completed its IDE (investigational device exemption) submission to the FDA to begin human trials of its AbioCor replacement heart and that it hopes to perform the first implant in the first half of 2001.
"The completion of the AbioCor IDE submission is a major milestone on the path to bringing heart replacement technology to the tens of thousands of people in heart failure who have little hope of receiving a human heart transplant," said Dr. David M. Lederman, Abiomed's president and CEO.
According to Dr. Robert T.V. Kung, Abiomed's chief scientific officer, the goals of initial trials in humans "will be to demonstrate improved life expectancy with a reasonable quality of life for selected patients who are in endstage heart failure and who are not candidates for heart transplantation or any other available therapy."
Abiomed's U.S. clinical centers are Brigham and Women's Hospital teamed with Massachusetts General Hospital, Boston; Hahnemann University Hospital, Philadelphia; Jewish Heart and Lung Hospital, Louisville, Kentucky; Texas Heart Institute, Houston; and UCLA Medical Center, Los Angeles.
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