24.08.2006 12:30:00
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Abiomed Announces Heart Recovery Technology Presentations at International Society of Rotary Blood Pumps Meeting
Presentations on Abiomed's Heart Recovery Technology, includingthe Impella(R) Recover 2.5 and Impella Recover(R) 5.0, the world'ssmallest 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 Alstrom, Dr. Ove Jonsson, Dr. Goran 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(R) 2.5 is a minimally invasive ventricularunloading catheter, which is inserted percutaneously via the femoralartery into the left ventricle. Up to 2.5 liters of blood per minuteare delivered by the pump from the left ventricle into the ascendingaorta, providing the heart with active support in critical situations.The device is CE Marked and has been the subject of more than 10papers. Abiomed recently announced it received FDA approval tocommence its pilot clinical trial in the United States for the Impella2.5.
The Impella(R) 5.0 unique, catheter-based Circulatory SupportSystems, are currently in pilot clinical trials in the U.S. and areavailable in Europe under CE Mark approval. The Impella 5.0 technologyconsists of catheters that can be introduced percutaneously through acut-down and surgically. The Impella 5.0 devices have been used inEuropean centers to support patients with postcardiotomy failure towean, post percutaneous coronary intervention (PCI), myocarditis,cardiogenic shock, or used as a bridge-to-next decision. Abiomedrecently announced it received FDA approval to commence its pilotclinical trial in the United States for the Impella 5.0.
Abiomed's Impella Recover Devices also include the Recover(R) RD,the smallest right ventricular unloading catheter. The ImpellaRecover(R) RD is implantable and can deliver up to 6.0 liters of bloodper minute from the right atrium via the outlet graft to the pulmonaryartery.
The IMPELLA RECOVER(R) 5.0 and 2.5 are investigational deviceslimited by federal law solely to investigational use in the UnitedStates. Other IMPELLA devices, including the Recover(R) RD, are notyet available for sale in the United States.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc. is a leadingdeveloper, manufacturer and marketer of medical products designed toassist or replace the pumping function of the failing heart. Abiomedcurrently manufactures and sells the AB5000(TM) Circulatory SupportSystem and the BVS(R) 5000 Biventricular Support System for thetemporary support of all patients with failing but potentiallyrecoverable hearts. In Europe, Abiomed offers the IMPELLA(R)RECOVER(R) minimally invasive cardiovascular support systems under CEMark approval. The IMPELLA RECOVER(R) 5.0 and 2.5 are investigationaldevices limited by Federal Law solely to investigational use in theUnited States. Other IMPELLA devices, including the Recover(R) RD, arenot yet available for sale in the United States. The Company'sAbioCor(R) Implantable Replacement Heart was the subject of an initialclinical trial under an Investigational Device Exemption from theUnited States Food and Drug Administration. The AbioCor has not beenapproved for commercial distribution, and is not available for use orsale outside of the initial clinical trial. For additional informationplease visit: www.abiomed.com.
FORWARD-LOOKING STATEMENTS
This Release contains forward-looking statements, includingstatements regarding development of Abiomed's existing and newproducts, the Company's progress toward commercial growth, and futureopportunities. The Company's actual results may differ materially fromthose anticipated in these forward-looking statements based upon anumber of factors, including uncertainties associated withdevelopment, testing and related regulatory approvals, anticipatedfuture losses, complex manufacturing, high quality requirements,dependence on limited sources of supply, competition, technologicalchange, government regulation, future capital needs and uncertainty ofadditional financing and other risks and challenges detailed in theCompany's filings with the Securities and Exchange Commission,including the Annual Report filed on Form 10-K. Readers are cautionednot to place undue reliance on any forward-looking statements, whichspeak only as of the date of this Release. The Company undertakes noobligation to publicly release the results of any revisions to theseforward-looking statements that may be made to reflect events orcircumstances that occur after the date of this Release or to reflectthe occurrence of unanticipated events.
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