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Abiomed Expands Availability of Impella Circulatory Support Technologies with Regulatory Approvals in India.


DANVERS, Mass. -- 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
) today announced that the Office of the Drug Controller General (DCGI DCGI Drugs Controller General of India ) in India has granted registration for the Company's Impella 2.5 and Impella 5.0 circulatory support technologies. Abiomed plans to market these advanced medical devices through Interventional Technologies, Ltd, its distributor based in Mumbai, India.

"We are excited that interventional cardiologists in India will now have the opportunity to treat heart failure patients with the Impella circulatory support technologies," said V.M. Kasim, Chairman & Managing Director, Interventional Technologies, Ltd., India.

The Impella 2.5 is a ventricular assist catheter, which is inserted percutaneously in the catheterization catheterization

Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages.
 laboratory (cath lab) via the femoral artery femoral artery
n.
1. An artery with origin at the continuation of the external iliac artery, with branches to the pudendal, epigastric, circumflex iliac arteries, the deep artery of the thigh, and the descending genicular artery, and
 into the left ventricle left ventricle
n.
The chamber on the left side of the heart that receives the arterial blood from the left atrium and contracts to force it into the aorta.
. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. The Impella 2.5 can be inserted quickly and provides cardiovascular support for up to five days. The device is currently available in Europe under the CE Mark and is currently in pilot studies in the United States 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  (IDE).

"Abiomed is committed to expanding our global distribution and access to our heart recovery products. India represents an important market and we are pleased to provide hospitals and clinicians in the country with our Impella technologies, which help rest and recover the hearts of patients in acute failure," said Michael R. Minogue, Chairman, 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.  and President of Abiomed.

The Impella 5.0 technology consists of catheters that can be introduced percutaneously through a cut-down (Impella 5.0) or surgically (Impella LD5.0). These pumps can achieve flows of up to 5.0 liters per minute, and actively unload the ventricle ventricle /ven·tri·cle/ (ven´tri-k'l) a small cavity or chamber, as in the brain or heart.ventric´ular

ventricle of Arantius  the rhomboid fossa, especially its lower end.
, reducing myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart.

myocardial

pertaining to the muscular tissue of the heart (the myocardium).
 workload and oxygen consumption while increasing cardiac output cardiac output
n. Abbr. CO
The volume of blood pumped from the right or left ventricle in one minute. It is equal to the stroke volume multiplied by the heart rate.
 and coronary and end-organ perfusion. The Impella 5.0 support systems are intended to be used for up to seven days as left ventricular cardiac assist devices. These technologies are currently available in Europe under the CE Mark and are in pilot studies in the United States under an Investigational Device Exemption (IDE).

Impella products are investigational devices limited by Federal Law solely to investigational use in the United States and are not yet available for sale in the United States.

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 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) 
([R]) 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The Company also developed the AbioCor([R]) Implantable Replacement Heart. In Europe, Abiomed offers the Impella([R]) LP2.5, Impella([R]) LP5.0, Impella([R]) LD, the Impella([R]) RD and an Intra-Aortic Balloon and the iPulse[TM] console under CE Mark approval. The Impella([R]) 5.0 and 2.5 are investigational devices limited by Federal Law solely to investigational use in the United States. Other Impella devices and the iPulse[TM] combination console system are not yet available for sale in the United States. 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 Company's most recently filed quarterly report on Form 10-Q. 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.
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Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Mar 29, 2007
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