UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report: August 27, 2007
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(Date of earliest event reported)
ABIOMED, Inc.
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(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)
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 August 27, 2007, we received a letter from the U.S. Food and Drug
Administration, or FDA, granting us conditional approval to begin a pivotal
clinical trial in the United States for our Impella(R) 2.5 Circulatory Support
System. This approval is the result of the submission of the clinical results of
the safety pilot clinical trial. The pivotal study is conditional upon the
Company's submission of additional information to the FDA over the next 45 days
and will determine the safety and effectiveness of the Impella 2.5 as compared
to optimal medical management with an Intra-Aortic Balloon Pump during
"high-risk" angioplasty or when treating patients with low cardiac output and
triple vessel disease. The study is approved under category B2 status and the
trial sites are eligible for full reimbursement from the Centers for Medicare
and Medicaid. A copy of the press release we issued on August 30, 2007
announcing this approval is filed as exhibit 99.1 to this current report on form
8-K and is incorporated herein by reference. The information contained in this
report shall not be deemed "filed" for purposes of Section 18 of the Securities
Exchange Act of 1934 or otherwise subject to the liabilities of that Section,
nor shall it be deemed incorporated by reference in any filing under the
Securities Act of 1933 or the Securities Act of 1934, whether made before or
after the date hereof and regardless of any general incorporation language in
such filing, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Description
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99.1 Press Release dated August 30, 2007.
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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: August 30, 2007
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Exhibit Index
Exhibit Number Description
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99.1 Press release dated August 30, 2007.