Abiomed (ABMD) 8-K Regulation FD Disclosure

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