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RTTNews) - Abiomed, Inc. (ABMD:News ) said it received conditional approval from the U.S. Food and Drug Administration, or FDA, to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction, or STEMI.

The primary objective of the study is to assess whether the adjunctive use of the Impella 2.5 for 24 hours following primary percutaneous intervention, or PCI, for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care.

The primary endpoint of the study will be a cardiac MRI-assessed ratio of the final infarct area to the total area of myocardium that was at risk. This ratio will be measured at three to five days after treatment and then again at 90 days.

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Don