Abiomed, a provider of heart support technologies, has received conditional approval from the US Food and Drug Administration (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 (STEMI).
The Impella 2.5 is a minimally invasive, catheter-based cardiac assist device designed to directly unload the left ventricle, reduce myocardial workload and oxygen consumption and increase cardiac output and coronary and end-organ perfusion.
The primary objective of the study is to evaluate whether the adjunctive use of the Impella 2.5 for 24 hours following primary percutaneous intervention (PCI) for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care.
Abiomed chairman, president and CEO Michael Minogue said this will be the first Impella study to evaluate the potential therapeutic benefits of unloading and reducing the oxygen demand on the heart muscle and they are excited to explore more clinical benefits of Impella with this new, hemodynamically stable patient population.
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 and this ratio will be measured at three to five days after treatment and then again at 90 days.
The study is based on the hypothesis that Impella’s ability to directly unload the left ventricle will reduce overall infarct area relative to the total area at risk which has been demonstrated in previous animal studies.
The MINI-AMI study will enroll patients with acute anterior STEMI or large inferior STEMI, primary PCI performed within five hours of the onset of symptoms, patients undergoing emergent primary PCI of one culprit lesion in one major coronary vessel, and successful revascularization of the native coronary artery at the end of PCI.