Abiomed Impella 2.5, Instructions For Use Manual

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6.11 Impella
®
System for Use During Cardiogenic Shock
Figure 6.9 30-day outcomes (by device) between Impella Registry subgroups: Patients
likely to be eligible for RCTs vs. Patients likely to be excluded from RCTs (“salvage”
patients)
Figure 6.10 Survival to discharge outcomes (by device) between Impella Registry
subgroups: Patients likely to be eligible for RCTs vs. Patients likely to be excluded from
RCTs (“salvage” patients)
BENCHMARKING IMPELLA VS. APPROVED VAD IN AMICS
In order to provide a benchmark for the Impella devices in a comparable clinical setting (AMICS),
Abiomed analyzed the results from its real-world registry for the AB5000 Ventricle. The AB5000
Ventricle was PMA approved (P900023/S038) in 2003 as a temporary VAD for use to treat
AMICS. The AB5000 Registry was a retrospective registry, which included data collected from
U.S. sites between October 3, 2003 and December 11, 2007. The AB5000 Registry included data
with demographics, procedural and hemodynamic characteristics, outcomes and adverse events.
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