![]() 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 |