Abiomed Impella 2.5, Instructions For Use Manual

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6.12 Instructions for Use & Clinical Reference Manual (US)
The AB5000 Registry includes 2,152 patients. After reviewing the AB5000 Registry and
matching the two cohorts (Impella and AB5000 for AMICS), 115 cases from the AB5000 Registry
were eligible match for the benchmark analysis.
The benchmark analysis included the overall survival to 30 days and to discharge in the AMICS
patient group. The 30-day Kaplan-Meier estimates are provided in Figure 6.11. The results are
provided for each Impella device. In addition, the survival-to-discharge results are provided in
Figure 6.12.
Figure 6.11 Kaplan-Meier curve estimates for 30-day survival
Figure 6.12 Survival to discharge in AMICS cohort
The trends in the Kaplan Meier curve support the assertion that outcomes are improved
when more robust hemodynamic support (i.e., flow) is provided to these hemodynamically
compromised patients. Indeed, Impella 5.0/LD and AB5000 initially exhibit the highest survival.
However, the data shows that the survival to discharge was significantly lower in the AB5000
cohort compared to the Impella cohort (30.43% vs. 45.68%, p=0.036), even though the