Attached files
| file | filename |
|---|---|
| 8-K - 8-K - ABIOMED INC | d620712d8k.htm |
 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 |