8-K

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 (Date of earliest event reported): October 29, 2013

ABIOMED, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware	001-09585	04-2743260
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification Number)

22 Cherry Hill Drive

Danvers, MA 01923

(Address of principal executive offices) (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 (see General Instruction A.2. below).

¨ 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 7.01 Regulation FD Disclosure.

On October 29, 2013, we held an investor meeting in San Francisco, California, at the annual Transcatheter Cardiovascular Therapeutics conference (“TCT2013”). A copy of selected slides used in the presentation at the investor meeting is attached as Exhibit 99.1 to this current report on Form 8-K and incorporated herein by reference. The selected slides provide an update on our current Impella^® 2.5 515 Pre-Market Approval (PMA) FDA regulatory filing and our Impella RP RECOVER RIGHT Humanitarian Device Exemption (HDE) clinical trial.

The information contained in this Item 7.01 and Exhibit 99.1 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

Number	Description
99.1	Abiomed Presentation to Investors dated October 29, 2013 – Selected Slides

2

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/ Robert L. Bowen
	Robert L. Bowen
	Vice President and Chief Financial Officer

Date: October 29, 2013

3

EX-99.1

515 FDA Clinical & Regulatory Execution

4 of 5 modules submitted for Impella PMA

1

515 PMA Process

Timing

FDA approval of proposed PMA

Shell

July 25

Module 1: Biocompatibility &

Animal  Testing

July 30

Module 2: Software Testing

July 31

Module 3: Bench & Shelf Life

Testing

Sept. 30

Module 4: Manufacturing &

Quality Systems

Sept. 30

Module 5: Clinical Analysis

Feb 2014

“FDA agrees with your proposed shell

and you may begin submitting modules

upon receipt of this letter”

Exhibit 99.1

Goal

#4

Executing

Impella

®

RP

FDA

Study

•

Catheter-based percutaneous VAD

(22 Fr pump on 11 Fr catheter)

•

Treatment: Right ventricular dysfunction

•

Flow: > 4 L/min

•

Duration of support: up to 14 days

2

outflow

inflow

RECOVER RIGHT Study

•

2 cohorts, 15 sites

•

8 IRBs approved (+3 pending)

•

30 patients; > 1/3 enrolled

IMPELLA®

RP (Right Percutaneous) is not approved by FDA for sale in the U.S.

Goal

#4