Form 8-K

-----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, DvExKoVYaBOZ9lVuJEhjCJ5d0cvG2bwtaNG5u2Vrfk3n1rGOqrBaxEMKZVkYbr9K dhDVP1DMNV32cmG6VVON2w== 0001193125-10-284193.txt : 20101220 0001193125-10-284193.hdr.sgml : 20101220 20101220132836 ACCESSION NUMBER: 0001193125-10-284193 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20101220 ITEM INFORMATION: Other Events FILED AS OF DATE: 20101220 DATE AS OF CHANGE: 20101220 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: 101262365 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 d8k.htm FORM 8-K Form 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: December 20, 2010

(Date of earliest event reported)

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 December 6, 2010, we issued a press release reporting the interim results of our Impella Protect II trial. Subsequent to that date, we identified an error in a p-value originally reported to us by the reporting academic research organization. A p-value of p=0.11 was reported for a subgroup representing 88% of patients (patients without atherectomy (n=267)). The correct p-value is p=0.06. A corrected table of the interim results of the trial is set forth below.

PROTECT II Per Protocol Patients With and Without Atherectomy


Patients (Interim: 305 patients)	% Interim Study Population			Impella Major Adverse Event Rate			IAB Major Adverse Event Rate			p value
All patients (n=305, at 30 days)		100	%		38	%		43	%		p=0.40
Patients without atherectomy (n=267)		88	%		32	%		43	%		p=0.06
Patients with atherectomy (n=38)* (Impella n=25, IAB n=13, p=0.04)		12	%		72	%		46	%		p=0.12

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/ MICHAEL R. MINOGUE
		Michael R. Minogue
		President and Chief Executive Officer

Date: December 20, 2010

-----END PRIVACY-ENHANCED MESSAGE-----