DANVERS, Mass. and Leuven, Belgium (August 24, 2006)-Abiomed, Inc. (NASDAQ: ABMD) today announced its schedule of events at the 14th Congress for the International Society of Rotary Blood Pumps (ISRBP) in Leuven, Belgium from August 31 through September 2, 2006.
Presentations on Abiomed's Heart Recovery Technology, including the Impella® Recover 2.5 and Impella Recover® 5.0, the world's smallest Ventricular Assist Devices (VADs), will include:
" "Platform Technology: Analysis of the System Periphery," by Dr. Thorsten Siess, Chief Technology Officer, Impella. The presentation, number 103, is scheduled in the session entitled 'Externals and User Interface' starting at 5:15 PM on August 31.
" "Development of an Electronic Controller Module for Micro-Axial Blood Pumps for Cardiac Support," by Sebastian Schwandtner, Director of Electronics R&D, Abiomed Europe. The presentation, number 96, is scheduled in the session 'Pump Design II - Design Modalities' starting at 3:30 PM on September 1.
" "The Smallest Available Right Ventricular Assist Device, the Impella Recover RD," by Christoph Nix, Director of Clinical Affairs, Abiomed Europe. The presentation, number 116, will also be included in the 'Pump Design II - Design Modalities' session on September 1 starting at 3:30 PM.
" "Acute MI (Myocardial Infarction) and Cardiogenic Shock: Where are We Now?" by Dr. Joseph Dens, Department of Cardiology, Ziekenhuis Oost-Limburg Genk, Belgium from 10:30 AM-12:00 PM on September 2.
" Also included in the session at 10:30 AM on September 2 is a presentation entitled "Safety and Feasibility of Elective High-Risk Percutaneous Coronary Intervention Procedures with Left Ventricular Support of the Impella Recover LP 2.5," by Dr. Rob de Winter, Head of the Cath Lab of the Academic Medical Center in Amsterdam.
" "A Two Year Clinical Experience of the Impella Recover and Ventricular Unloading System," at 3:15 PM on September 2 by Dr. Ulf Kjellman, Dr. Laila Hellgren, Dr. Erik Wassberg, Dr. Jan Hultman, Dr. P.O. Joachimsson, Dr. Ursula Alström, Dr. Ove Jonsson, Dr. Göran Dellgren, and Dr. Gunnar Myrdal, from the Department of Cardio-Thoracic Surgery, University Hospital, Uppsala, Sweden
More information on the ISRBP can be found at: http://www.kuleuven.ac.be/isrbp2006/
ABOUT THE IMPELLA RECOVER DEVICES
The Impella Recover® 2.5 is a minimally invasive ventricular unloading catheter, which is inserted percutaneously via the femoral artery into the left ventricle. 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 device is CE Marked and has been the subject of more than 10 papers. Abiomed recently announced it received FDA approval to commence its pilot clinical trial in the United States for the Impella 2.5.
The Impella® 5.0 unique, catheter-based Circulatory Support Systems, are currently in pilot clinical trials in the U.S. and are available in Europe under CE Mark approval. The Impella 5.0 technology consists of catheters that can be introduced percutaneously through a cut-down and surgically. The Impella 5.0 devices have been used in European centers to support patients with postcardiotomy failure to wean, post percutaneous coronary intervention (PCI), myocarditis, cardiogenic shock, or used as a bridge-to-next decision. Abiomed recently announced it received FDA approval to commence its pilot clinical trial in the United States for the Impella 5.0.
Abiomed's Impella Recover Devices also include the Recover® RD, the smallest right ventricular unloading catheter. The Impella Recover® RD is implantable and can deliver up to 6.0 liters of blood per minute from the right atrium via the outlet graft to the pulmonary artery.
The IMPELLA RECOVER® 5.0 and 2.5 are investigational devices limited by federal law solely to investigational use in the United States. Other IMPELLA devices, including the Recover® RD, 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™ Circulatory Support System and the BVS® 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. In Europe, Abiomed offers the IMPELLA® RECOVER® minimally invasive cardiovascular support systems under CE Mark approval. The IMPELLA RECOVER® 5.0 and 2.5 are investigational devices limited by Federal Law solely to investigational use in the United States. Other IMPELLA devices, including the Recover® RD, are not yet available for sale in the United States. The Company's AbioCor® Implantable Replacement Heart was the subject of an initial clinical trial under an Investigational Device Exemption from the United States Food and Drug Administration. 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.
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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.
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