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ABIOMED Announces Selection of Additional European Centers of Excellence for AbioCor Clinical Trial.


Business Editors & Health/Medical Writers

DANVERS, Mass.--(BW HealthWire)--Nov. 8, 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
) announced today that The Heart Lung Center Utrecht (Utrecht, the Netherlands) and Lund University Lund University has 7 faculties, with additional campuses in the cities of Malmö and Helsingborg, with a total of over 42,500 people studying in 50 different programmes and 800 separate courses.  Hospital (Lund, Sweden) have been selected to participate in the European clinical trial of the AbioCor(TM) Implantable Replacement Heart. The European trial is expected to begin within the next six months. ABIOMED had previously announced the selection of the North Rhine-Westphalia Heart Center (Bad Oeynhausen, Germany) as an AbioCor European clinical trial site.

"We are extraordinarily pleased to have the Heart Lung Center Utrecht and Lund University Hospital working with us on the AbioCor trial,"said ABIOMED's Chief Executive Officer Dr. David M. Lederman. "We have a most successful and long-standing relationship with the Principal Investigators and their teams from previous scientific collaborations. They are each among the premier cardiothoracic surgery centers in Europe, with exceptionally strong transplant

and mechanical cardiac assist programs. Together with the North Rhine-Westphalia Heart Center in Germany, they provide a clinical and institutional foundation of unequalled strength for the European trial of the AbioCor Implantable Replacement Heart. These partnerships also signify ABIOMED's commitment to the development and growth of a strong European clinical, sales and distribution presence."

Dr. Jaap R. Lahpor, Director of the Heart Transplant and Mechanical Cardiac Assist Unit of the Heart Lung Center Utrecht commented that "We greatly appreciate the opportunity to become one of the first sites in Europe to take part in the initial AbioCor clinical trial. This is a clear recognition of the efforts we have successfully undertaken to maintain our leadership as a European Center of Excellence."

"I am delighted that we are now in the start-up phase for a multi-center, multi-national clinical trial for the AbioCor Implantable Replacement Heart," said Dr. B. Koul, Surgical Director of the Heart Transplant and the Artificial Heart Programs at the Lund University Hospital. "That ABIOMED has chosen Lund University Hospital to participate in the initial European trial of the AbioCor is a matter of pride and privilege for us."

The Heart Lung Center Utrecht is a collaboration of the departments of cardiothoracic surgery, cardiology and pulmonology pul·mo·nol·o·gy
n.
The branch of medicine that deals with diseases of the respiratory system.


pulmonology The study of the lungs and respiratory function
 of the University Medical Center Utrecht The Universitary Medical Center Utrecht (Dutch: Universitair Medisch Centrum Utrecht) or UMCU is the main hospital of the city of Utrecht. It is affiliated with the Universiteit Utrecht.  and the St. Antonius Hospital Nieuwegein in the Netherlands. It is the only center in the Netherlands recognized by the government as a heart lung transplant lung transplant Surgery Transplant of a lung allograft into a Pt with failing lungs; 90 US centers perform LT; 35 centers perform ≥ 10/yr Mean wait time 18 months Indications COPD–eg, emphysema due to α1  center. The Heart Lung Center annually performs more than 3,000 open heart surgeries, and has for more than a decade managed successful bridge to recovery and bridge to transplant cardiac assist programs using various ventricular assist devices ventricular assist device: see under heart, artificial. .

Lund University Hospital is one of the two major hospitals in Sweden Here is a list of hospitals in Sweden.
  • Västra Götaland County
  • Möndals Sjukhus - Möndal
  • Sahlgrenska University Hospital - Gothenburg
 performing thoracic organ transplantation The transfer of organs such as the kidneys, heart, or liver from one body to another.

The transplantation of human organs has become a common medical procedure. Typical organs transplanted are the kidneys, heart, liver, pancreas, cornea, skin, bones, and lungs.
 and pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 heart surgery, and is committed to the advancement of the quality of life in adult and pediatric patients with debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 heart disease. The clinic has achieved a 76% rate of 10-year survival following conventional cardiac transplantation, as well as a 94% transplantation/explantation rate following the use of currently available left ventricular assist systems. Dr. Koul's involvement with clinical use of total artificial hearts dates back to the 1980's.

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.

Based in Eindhoven, the Netherlands, ABIOMED BV is a European company in charge of distribution and clinical support of the BVS-5000 System and the overall management and support of the multinational European clinical trial with the AbioCor Heart.

This Release contains forward-looking statements, including statements regarding the anticipated timing and results of ongoing initial clinical trials in the United States and prospective trials in Europe with the AbioCor Implantable Replacement Heart. 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 8, 2001
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