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ABIOMED Home > News > ABIOMED Announces 13th Implant of AbioCor Replacement Heart |
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| ABIOMED Announces 13th Implant of AbioCor Replacement Heart | ||||||||||||||
| DANVERS,
Mass. (May 5, 2004) -- ABIOMED, Inc., (NASDAQ:ABMD) today
announced the 13th implantation of the AbioCor® Implantable Replacement
Heart. The implant was performed on May 3 in Louisville, KY by a Jewish
Hospital/University of Louisville medical team led by surgeons Laman
Gray, M.D. and Rob Dowling, M.D.. The procedure went well and without
complication. The patient is recovering in critical but stable condition.
Consistent with ABIOMED's established policy for the AbioCor clinical trial, no further patient information will be released at this time. Additional information will be available when the clinical team and the patient's family deem it is appropriate. A product of three decades of research, the AbioCor is the subject of an initial clinical trial that began when the first patient was successfully implanted in July 2001. 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. This Release contains forward-looking statements, including statements regarding future product development activities. ABIOMED’s actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing and other risks detailed in the Company’s filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events. 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. ### Media Contact: Investor Relations Contact:
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