September 5, 2006
Abiomed Receives FDA Approval of The AbioCor®, The World’s First Completely Self-Contained, Implantable Artificial Heart AbioCor Granted Humanitarian Device Exemption
Louisville, KY, September 5, 2006 --
Abiomed, Inc. announced today it has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for its AbioCor® Implantable Replacement Heart (AbioCor). Jewish Hospital will again be among the first U.S. hospitals to offer patients the AbioCor totally implantable replacement heart. The Jewish Hospital/University of Louisville team principal investigators and surgeons are Laman Gray, M.D., Rob Dowling, M.D., and Sanjeev Aggarwal, M.D.