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Abiomed Receives FDA 510(k) Clearance For New, Higher Flow Impella Percutaneous Heart Pump, With Peak Flows Of 4L/min


1. Indication: The Impella CP is "intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass."

2. For Impella CP only: "The safety and effectiveness of this device has not been established for use in providing partial or full support of the blood circulation for periods of greater than six hours, or for providing prophylactic hemodynamic support, for example, in patients with stable hemodynamics during percutaneous interventional procedures of high risk coronary artery lesions and/or anatomy."

3. Upon CE Marking approval, Abiomed partnered with nine key opinion leaders and institutions in the European Union to conduct a limited market release. This successful market evaluation validated the performance and ease of use of the new Impella pump, introducer, and Automated Impella Controller (AIC) operating software.


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:

The Abiomed logo is available at


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 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 and 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.
CONTACT: Aimee Maillett
         Corporate Communications Manager
         Susie Lisa
         Senior Director, Investor Relations, Corporate Development

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