Abiomed Impella 2.5, Instructions For Use Manual

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6.6 Instructions for Use & Clinical Reference Manual (US)
Figure 6.4 Change in inotropic dosage at 24 hours, Impella vs. IABP in patients treated
for cardiogenic shock after an AMI (ISAR-SHOCK)
DEVICE FAILURES AND REPLACEMENTS
There were no device failures or replacements reported during the study.
FINANCIAL DISCLOSURE
The Financial Disclosure by Clinical Investigators regulation (21 CFR 54) requires applicants who
submit a marketing application to include certain information concerning the compensation to,
and financial interests and arrangement of, any clinical investigator conducting clinical studies
covered by the regulation. This clinical study included 2 investigators. Neither of the clinical
investigators had disclosable financial interests/arrangements as defined in sections 54.2(a), (b),
(c), and (f). The information provided does not raise any questions about the reliability of the
data.