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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report: January 7, 2008
(Date of earliest event reported)
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ABIOMED, Inc.
(Exact name of registrant as specified in its charter)
Delaware 04-2743260
(State or other Jurisdiction (IRS Employer
of Incorporation) Identification Number)
0-20584
(Commission File Number)
22 Cherry Hill Drive
Danvers, MA 01923
(Address of Principal Executive Offices, including Zip Code)
(978) 646-1400
(Registrant's Telephone Number, including Area Code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
|_| Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
|_| Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
|_| Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c)
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Item 8.01 Other Events.
On January 7, 2008 the Company announced it had submitted what the Company
believes to be the final response to the U.S. Food and Drug Administration (FDA)
in connection with its submission for 510(k) clearance for its Impella 2.5
circulatory support device. This response included data related to use of the
Impella 2.5 treating 35 patients and the Company believes that the respective
data demonstrates the device's safety based on an audit from an independent
third party group. The Company stated that the submission also referenced data
related to the treatment of hundreds of patients from European peer-reviewed
studies. The Company also indicated that the predicate devices were approved
without any respective clinical data. The Impella 2.5 device is approved in
Europe under CE-mark. The Company expects to receive a response from the FDA on
its 510(k) clearance submission sometime before March 31, 2008.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
ABIOMED, Inc.
By: /s/ Daniel J. Sutherby
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Daniel J. Sutherby
Chief Financial Officer
Date: January 7, 2008