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Abiomed Receives Close-Out Letter From Food and Drug Administration

2013-02-20 16:00 ET - News Release

DANVERS, Mass., Feb. 20, 2013 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that on February 19, 2013, Abiomed received a close-out letter from the Food and Drug Administration, Office of Compliance with respect to its previous FDA warning letter dated June 10, 2011.

The close-out letter states that the FDA Office of Compliance has completed its evaluation of the corrective actions taken by Abiomed in response to the previously disclosed FDA warning letter and that the concerns cited in that letter appear to have been addressed.

ABOUT ABIOMED

Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.

The Abiomed logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13564

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 and expected regulatory approvals. 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, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, 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 most recently filed Annual Report on Form 10-K and 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.

CONTACT: For further information please contact:
         
         Susie Lisa, CFA
         Senior Director, Investor Relations and Corporate Development
         978-646-1590
         slisa@abiomed.com
         
         Aimee Maillett
         Corporate Communications Manager
         978-646-1553
         ir@abiomed.com

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