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ABIOMED Announces French Regulatory Approval of the AB5000 Circulatory Support System; ABIOMED to Open French Office for Direct Sales and Clinical Support for Customers.


DANVERS, Mass. and AACHEN, Germany -- 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
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ABMD Advanced Ballistic Missile Defense
) today announced that the French regulatory agency for medical devices, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS AFSSAPS Agence Francaise de Securite Sanitaire des Produits de Sante ) has granted approval of the AB5000(TM) Circulatory Support System. France represents one of the largest medical device markets in Europe. All of ABIOMED's Circulatory Support Systems including the IMPELLA products are now available in France, providing French patients in acute heart failure with access to life-saving circulatory support. In addition, ABIOMED announced plans to open an office in Paris to provide French customers with direct customer service, and sales and clinical expertise as they incorporate Ventricular Assist Device ventricular assist device: see under heart, artificial.  (VAD (Value Added Dealer) Same as VAR. ) Recovery Programs into standard clinical practice.

The AB5000 is a VAD that was designed to rest and recover a patient's heart following such events as cardiogenic shock resulting from myocardial infarction, myocarditis Myocarditis Definition

Myocarditis is an inflammatory disease of the heart muscle (myocardium) that can result from a variety of causes. While most cases are produced by a viral infection, an inflammation of the heart muscle may also be instigated by
, postpartum cardiomyopathy, ventricular septal defect Ventricular Septal Defect Definition

A ventricular septal defect is a hole in the wall of the heart (septum) that separates the left lower chamber (left ventricle) from the right lower chamber (right ventricle).
, refractory arrhythmias, failed heart transplants, right ventricular assistance with implantable LVAD LVAD left ventricular assist device; see ventricular assist device, under device.  (Left Ventricular Assist Device left ventricular assist device Cardiology A mechanical device to ↑ force and volume of blood flowing through the heart. Cf CABG, Jarvik-7. ), and postcardiotomy cardiogenic shock (PCCS PCCS Primary Care Cardiovascular Society (UK)
PCCS Passive Containment Cooling System
PCCS Senior Chief Postal Clerk (Naval Rating)
PCCS Planning Conference on Computer Systems
PCCS Ported Coaxial Cable System
). The ABIOMED(R) AB5000(TM) System also allows patients to walk with the support of the console.

"We are excited by the momentum in Europe overall and also with this new access to the French market," stated Michael R. Minogue, Chairman, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of ABIOMED. "The U.S. clinical data supporting heart recovery using our technology is extensive and we are seeing increased utilization worldwide. Our plan for a new office in France demonstrates our strong commitment to work closely with our customers and clinical leaders in France to assist in the development of Recovery Programs for their patients."

ABIOMED has exclusive labeling in the United States for recovery indications through its AB5000 and BVS 5000 platforms. The Company's global sales and clinical teams now total more than 45 individuals and the Company announced recently its intention to hire 2-4 additional sales and clinical professionals globally per quarter in fiscal 2007.

ABOUT THE AB5000(TM) Circulatory Support System

The AB5000 was 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.
 approved in September 2003 to provide temporary support for one or both sides of the natural heart in circumstances where the heart has failed, giving the patient's heart the opportunity to rest and potentially recover - and giving surgeons the therapeutic flexibility necessary to determine the best endpoint for treatment. The AB5000 and the BVS 5000 are the only devices with recovery labeling in the United States.

The AB5000(TM) Ventricle, a major component of the AB5000 Circulatory Support System, is a pneumatically driven blood pump. The sterile, disposable Ventricle provides circulatory support in the presence of left-, right-, or both-sided heart failure. The Ventricle is located next to the body (paracorporeal) and can take over the pumping function of the natural heart. Assisted by vacuum, blood flows from the native heart into the AB5000 Ventricle bladder. The bladder, which holds about 100 cc of blood, fills and empties much like the natural heart. Connection of the Ventricle to the patient is accomplished by connecting the pump to cannulae, or tubes, implanted in the patient's heart. These tubes pass through the patient's skin and connect directly to the AB5000(TM) Console.

ABOUT ABIOMED

Based in Danvers, Massachusetts, ABIOMED, Inc. 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(TM) Circulatory Support System and the BVS(R) 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. In Europe, ABIOMED offers the IMPELLA(R) RECOVER(R) minimally invasive cardiovascular support systems under CE Mark approval. The IMPELLA products are not yet available for sale in the United States. The Company's AbioCor(R) Implantable Replacement Heart was the subject of an initial clinical trial 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. For additional information please visit: www.abiomed.com.

FORWARD-LOOKING STATEMENTS

This Release contains forward-looking statements, including statements regarding development of ABIOMED's existing and new products, the Company's progress toward commercial growth, and future opportunities. The Company'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 and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K. 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 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Comment:ABIOMED Announces French Regulatory Approval of the AB5000 Circulatory Support System; ABIOMED to Open French Office for Direct Sales and Clinical Support for Customers.
Publication:Business Wire
Geographic Code:1USA
Date:May 22, 2006
Words:843
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