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Press Contact:
Liza Heapes
Ph: 978-646-1668
Email: lheapes@abiomed.com

 
Cause of Death is Pre-existing Multi-Organ Failure

Danvers, Mass., May 17, 2004 -- ABIOMED, Inc. (NASDAQ: ABMD) announced today that Dr. Bud Frazier, investigator for the AbioCor® clinical trial at the Texas Heart Institute, has reported that the family of the twelfth AbioCor patient opted to take him off support on Sunday, May 16th. This decision was made in consultation with the medical team as a result of unrecoverable liver and kidney failure, conditions that pre-dated the AbioCor implant. During his 85 days on support, no thrombo-embolic strokes, device malfunctions or other significant adverse events related to the AbioCor were observed.

The patient, 63 year-old Jay Croft, received the AbioCor on February 20, 2004.

"On behalf of the entire ABIOMED team, I wish to offer condolences to the family of this brave patient who chose to participate in this experimental trial to extend his life and help ensure extended life for future heart failure patients," said Michael R. Minogue, President and CEO of ABIOMED. "We are grateful for the contribution he and his family chose to make. Our thoughts and prayers are with them during this time. "

Candidates for the clinical trial must suffer from biventricular heart failure, be ineligible for heart transplantation and not able to be helped by any other available therapy, and have a high probability of dying in less than 30 days. ABIOMED has announced its intention to seek initial FDA market approval this year for the AbioCor to treat a defined subset of irreversible end-stage heart failure patients under a Humanitarian Device Exemption.

Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced “AB’-EE-O-MED”) is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. ABIOMED currently manufactures and sells the AB5000™ Circulatory Support System and the BVS® 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The Company’s AbioCor® Implantable Replacement Heart is the subject of an initial clinical trial being conducted under an Investigational Device Exemption from the United States Food and Drug Administration. The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial.

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