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ABIOMED Statement On Setback Suffered by Robert Tools, First AbioCor Patient.


Business Editors and Health/Medical Writers

DANVERS, Mass.--(BW HealthWire)--Nov. 14, 2001

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
), developers of the AbioCor(TM) Implantable Replacement Heart, today issued the following statement by Dr. David M. Lederman, Chief Executive Officer, concerning the status of Robert Tools Robert L. Tools (July 31 1942 - November 30 2001), was the world's first recipient of a fully self-contained artificial heart called AbioCor. The operation took place on July 2, 2001. He survived for 151 days without a living heart. Dr. , who suffered a serious stroke on Sunday, November 11:

"The thoughts and hopes of every ABIOMED employee are with Bob Tools and his family as he confronts this new challenge. If fighting spirit Fighting Spirit may refer to:
  • Fighting Spirit (anime), a boxing anime and manga series
  • Victorious Boxers 2: Fighting Spirit, a boxing video game for the PlayStation 2 based on the anime/manga series.
 can make a difference, we know that Bob will make the fullest possible recovery.

Currently there is insufficient information to determine the precise cause of the thrombo-embolic event that appears to have caused Mr. Tools' stroke. ABIOMED technical personnel are working closely with the clinical team 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/
 to determine what factors may have contributed to this event, and therefore how such potential events might be prevented in the future. It is noteworthy that, because of persistent gastrointestinal bleeding gastrointestinal bleeding Any hemorrhage into the GI tract lumen, from esophagus–eg, from ruptured esophageal varices, to anus–eg from hemorrhoids  episodes due to his pre-implant condition, it has proved impossible during extended periods since his implant to provide Mr. Tools with the anticoagulation regimen called for in the AbioCor clinical trial protocol A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in . Anticoagulation is one important area of inquiry, but we will be looking at numerous other variables as well, in order to fully understand what has occurred.

In addition to working with clinicians at Jewish Hospital, ABIOMED will also be communicating with the clinical teams at other AbioCor trial sites to share information as quickly as possible regarding the cause of Mr. Tools' stroke and any measures determined necessary to lessen the potential for such events in other AbioCor patients.

ABIOMED continues to monitor the functional performance of Mr. Tools' replacement heart. The AbioCor appears to be functioning well and Mr. Tools' blood flow remains satisfactory.

Finally, we do not anticipate that this setback for Mr. Tools will cause any interruption or delay in the progress of the AbioCor clinical trial. Having completed the initial five AbioCor implants, we expect to be 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.
 to proceed. We believe that the cumulative record to date provides more than sufficient basis to continue the trial."

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. 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 forward-looking statements, including statements regarding FDA authorization to continue to enroll patients in the AbioCor trial, and the anticipated timing and results of the clinical trials for the AbioCor. 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.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Nov 14, 2001
Words:628
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