-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, E0plXAC/XqZx7oE3yQ2DzRKE0B3hxJ6YjFt+aWCsqsP54rUS4fU/E1zq9kRua6MS cpiOPqbMdmS1dkw4osOFXg== 0001157523-08-004702.txt : 20080602 0001157523-08-004702.hdr.sgml : 20080602 20080602073008 ACCESSION NUMBER: 0001157523-08-004702 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080530 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080602 DATE AS OF CHANGE: 20080602 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ABIOMED INC CENTRAL INDEX KEY: 0000815094 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 042743260 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09585 FILM NUMBER: 08872338 BUSINESS ADDRESS: STREET 1: 22 CHERRY HILL DR CITY: DANVERS STATE: MA ZIP: 01923 BUSINESS PHONE: 9787775410 MAIL ADDRESS: STREET 1: 22 CHERRY HILL DRIVE CITY: DANVERS STATE: MA ZIP: 01923 8-K 1 a5698638.htm ABIOMED, INC. 8-K

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: June 2, 2008


(Date of earliest event reported May 30, 2008)

ABIOMED, Inc.


(Exact name of registrant as specified in its charter)

Delaware

04-2743260

(State or other Jurisdiction of Incorporation)

(IRS Employer 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))





Item 8.01     Other Events.

On June 2, 2008, we issued a press release announcing we received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for our Impella 2.5 Cardiac Assist Device.  A copy of the press release is set forth as Exhibit 99.1 and is incorporated by reference herein.   

Item 9.01     Financial Statements and Exhibits.

(d) Exhibits

 

Number

 

Title

99.1 Press Release dated June 2, 2008



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 hereunto duly authorized.

Abiomed, Inc.

 

 

 

By:

/s/    Daniel J. Sutherby

Daniel J. Sutherby

Chief Financial Officer

Date:

June 2, 2008

EX-99.1 2 a5698638ex991.htm EXHIBIT 99.1

Exhibit 99.1

Abiomed Receives 510(k) Clearance from FDA for Impella 2.5 Device

  • Worlds Smallest Heart Pump Available to Doctors and Patients in the U.S.
  • Abiomed Conference Call Scheduled for June 2, 2008 at 8:30AM ET

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Impella 2.5 Cardiac Assist Device. This 510(k) clearance allows Abiomed to begin selling the device to the estimated 14,000 interventional cardiologists at approximately 1,700 heart hospitals in the United States.

“FDA clearance of the Abiomed Impella 2.5 represents the next step in enabling heart recovery for patients in the U.S. and will likely change the standard of care in the catheterization lab,” said Michael R. Minogue, Chairman, Chief Executive Officer and President of Abiomed. “The device seamlessly provides immediate, minimally invasive circulatory support for critical patients.”

The Impella 2.5 is inserted percutaneously in the catheterization laboratory (cath lab) via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations.

The Impella 2.5 is cleared for use under the 510(k) for partial circulatory support for periods up to six hours. The intra-aortic balloon pump (IABP) also has 510(k) clearance and approximately 110,000 are used each year in the United States. Abiomed is currently conducting two U.S. pivotal studies comparing the Impella 2.5 to the IABP.

The Impella 2.5 is now approved in more than 40 countries, including in Europe for up to seven days of support under the CE Mark. The Impella platform has been used to treat over 1,500 patients outside the U.S. and has been the subject of more than 40 peer reviewed publications.

The Company will host a conference call today, June 2, 2008, at 8:30 a.m. ET to discuss the clearance of the Impella 2.5 cardiac assist device. Michael R. Minogue, Chairman, Chief Executive Officer and President will host the conference call.

To listen to the call live, please tune into the webcast via http://investor.abiomed.com or dial 866.362.5158; the international number is 617.597.5397. The access code is 37053565. A replay of this conference call will be available beginning at 10:30 a.m. ET on June 2, 2008 through 11:59 p.m. ET on July 2, 2008. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 27621107.

ABOUT ABIOMED

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


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, 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 recently filed 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:
Abiomed, Inc.
Daniel J. Sutherby, 978-777-5410
Chief Financial Officer
ir@abiomed.com
or
For Abiomed, Inc.
Brodeur
Heather Nevers, 617-587-2814
Media Relations
hnevers@brodeur.com

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