Abiomed Impella 2.5, Instructions For Use Manual

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6.24 Instructions for Use & Clinical Reference Manual (US)
Cases were initially identified using Abiomed’s commercial patient tracking system. Using this
method, sixty-three (63) Impella cases were enrolled into the U.S. Impella Registry for this
analysis. These included 17 Impella 2.5 cases and 56 (combined) Impella 5.0 and Impella LD
cases.
The overall results (Kaplan-Meier curve estimates) for survival (to 30 days) for the patients are
shown in Figure 6.18. Figure 6.19 provides the results for the different devices used. Overall
outcome results appear favorable for this sick patient group, particularly when compared to the
historical results for similar patients (see the benchmark and literature review sections below).
Figure 6.18 Kaplan-Meier curve estimates for 30 day survival – all patients cohort
Figure 6.19 Kaplan-Meier curve estimates for 30 day survival – for difference devices
In addition, analyses were completed using two different classification schemes. In one analysis,
Classification A, the patients were categorized in three (3) different groups based on an
incremental ascending risk for mortality, which were: (1) Post-cardiotomy Low Cardiac Output
Syndrome (LCOS), (2) Post-cardiotomy Cardiogenic Shock (PCCS-CS) and (3) Post-cardiotomy