Atrium Medical commences enrollment in its INFUSE AMI trial

Atrium Medical Corporation announced that the 1st patient was enrolled in the INFUSE AMI trial. INFUSE AMI is a multi-center, multi-national, prospective, randomized, single blind trial examining how patients with heart attacks are treated. The study's aim is to help determine the best way to treat patients with an acute anterior wall myocardial infarction (acute MI) with ST segment elevation, commonly referred to as STEMIs.

INFUSE AMI will enroll 452 patients at up to 40 sites in the U.S. and Europe in a 2 by 2 factorial design (4 study arms). The study will assess 4 different ways to treat the blood clot (thrombus) causing the heart attack. These include: Intracoronary (IC) infusion of abciximab* via Atrium's ClearWay™ RX Local Therapeutic Infusion catheter, thrombus aspiration, thrombus aspiration followed by IC infusion of abciximab* with ClearWay™ RX, and the current standard of care which is traditional percutaneous coronary intervention (PCI), often with a stent. This study will help to identify which of these four study arms can provide better patient outcomes with the goal of reducing the infarct size (heart muscle damage) during a heart attack and restoring flow in the infarct related artery and microvasculature in the heart muscle. The study's endpoints will include measuring infarct size at 30 days using a powerful new imaging technique called cardiac MRI, microvascular obstruction, ST segment resolution, myocardial perfusion, impact on thrombus burden, and outcomes on bleeding.

Atrium's novel ClearWay™ RX Local Therapeutic Infusion catheter, which is being utilized in two arms of the trial, provides super selective, local intracoronary infusion of medication, allowing more medication to act locally at a higher concentration and for a longer period of time to enhance its therapeutic effect on the occluding blood clot and diseased artery.