FDA permits Abiomed to commence new Impella trial

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

Abiomed, a developer of heart support technologies, has received conditional approval from the FDA to begin MINI-AMI, a prospective, randomized, controlled multisite trial to assess the potential role of the Impella 2.5 in reducing infarct size in patients with STEMI.

The primary objective of this study is to evaluate whether the adjunctive use of the Impella 2.5 for 24 hours following primary PCI for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care, according to the Danvers, Mass.-based company.

“This pilot study will determine whether the Impella 2.5 can … shrink infarct size," said principal investigator Jeffrey W. Moses, MD, from New York-Presbyterian Hospital and Columbia University Medical Center in New York City. “The intent of this study is to investigate the unique unloading capabilities of Impella 2.5 and its effect in potentially reducing infarct size and improving quality of life for patients.”

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. A total of 50 patients at five hospital sites will be randomized to Impella 2.5 support or the institution’s standard of care with no circulatory support post-PCI, Abiomed said.