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AbioCor Implant Performed at Jewish Hospital, Patient Does Not Survive.


Business Editors and Health/Medical Writers

DANVERS, Mass.--(BW HealthWire)--April 11, 2002

ABIOMED, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ABMD ABMD areal bone mineral density
ABMD AEGIS Ballistic Missile Defense (US Navy)
ABMD Advanced Ballistic Missile Defense
) reported today that an AbioCor(TM) clinical trial implant was performed yesterday by University of Louisville See also
  • The University of Louisville Cardinal Singers
  • The University of Louisville Collegiate Chorale
  • History of Louisville, Kentucky
  • McConnell Center
References

1. ^ [1]
2. ^ [2] URL accessed on June 8 2006
3.
 surgeons Drs. Laman A. Gray and Robert D. Dowling at Jewish Hospital Jewish Hospital can refer to:
  • Barnes-Jewish Hospital, St. Louis, Missouri
  • Jewish Hospital, Cincinnati, Ohio http://www.jewishhospitalcincinnati.com/
  • Long Island Jewish Hospital, Long Island, New York
  • Jewish Hospital, Louisville, Kentucky http://www.jhhs.org/
 in Louisville, KY. As reported by Jewish Hospital, the AbioCor functioned as expected, but the patient died post-operatively. The AbioCor multidisciplinary team is actively reviewing all details of the case. Additional information may be available once this review is completed. This implant is the seventh of fifteen authorized by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 for the initial AbioCor clinical trial.

"ABIOMED's sincerest condolences go out to this patient's family," said Dr. David M. Lederman, ABIOMED's Chief Executive Officer. "We also want to extend our deepest gratitude to the entire Jewish Hospital team for their valiant efforts. Events of this kind are unavoidable in any clinical trial involving surgical intervention with such gravely ill patients; that does not make them easier to accept. At the same time we are resolved to move forward with the AbioCor trial and we are in no way discouraged. We look forward eagerly and optimistically to completing all of the implants that have been authorized by the FDA consistent with our clinical trial plan."

Out of respect for the patient's family at this time of loss, and to protect their privacy, any further details, including the patient's name, will not be released at this time.

Based in Danvers, Massachusetts Danvers is a town in Essex County, Massachusetts, United States. Located on the Danvers River near the northeastern coast of Massachusetts, Danvers is most widely known for its association with the 1692 Salem witch trials. , 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. The Company's AbioCor Implantable Replacement Heart is being implanted in patients as part of an initial clinical trial conducted under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  from the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
. The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. ABIOMED currently manufactures and sells the BVS BVS Biblioteca Virtual em Saúde (Brazil)
BVS Bureau of Vital Statistics
BVS Brethren Volunteer Service (Church of the Brethren)
BVS Boston Vegetarian Society (Cambridge, MA) 
, a heart assist device for the temporary support of all patients with failing but potentially recoverable hearts.

This Release contains references to clinical trials for the AbioCor. Clinical trials are subject to significant risks. ABIOMED's actual results may differ materially from those anticipated for the clinical trials 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. Investors are encouraged to consider these risks and cautioned not to place undue reliance on any forward-looking statements regarding these clinical trials.
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Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 11, 2002
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