HUDSON, NH--(Marketwire - December 07, 2009) - 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.
The multi-national INFUSE AMI trial is being led by the Clinical Research Foundation (CRF) in New York City. Dr. Gregg Stone, Director of Cardiovascular Research and Education at New York Presbyterian & Columbia University Medical Center, is the principal investigator and Dr. Michael Gibson, Chief of Clinical Research at Beth Israel Deaconess Medical Center/Harvard Medical School (Boston, MA), is the co-principal investigator. The first patient was enrolled by Dr. Jochen Wöhrle at the University of Ulm in Ulm, Germany on November 28, 2009.
About the Atrium ClearWay™ RX Local Therapeutic Infusion Catheter
ClearWay™ RX Local Therapeutic Infusion Catheter is an extraordinarily thin, microporous PTFE balloon mounted on a .014" rapid exchange catheter. The ClearWay™ RX allows for a super selective infusion of a prescribed amount of drug into a localized targeted area. The balloon controllably engages the vessel wall to gently and atraumatically occlude blood flow during infusion thus providing up to 500 times the systemic concentration at the local site of delivery. ClearWay™ RX maximizes drug availability, concentration, and residence time to greatly enhance the desired therapeutic effect. ClearWay™ RX is available in 1.0 to 4.0 mm balloon diameters and in balloon lengths ranging from 20 to 50 mm.
About Atrium
Atrium’s vast expertise in medical device technologies for the treatment of coronary and vascular disease, chest trauma, hernia and soft tissue injury has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery, and general surgery. Maintaining a commitment to the latest ISO13485 Quality Standards, state-of-the-art manufacturing and automation, cell biology and biomaterial discovery programs, Atrium continues to excel in those healthcare segments that require more advanced surgical intervention for improvements in patient outcomes. For more information please call Atrium’s Marketing Communications Dept. at 1-800-370-7899 or visit Atrium’s website at www.atriummed.com.
ClearWay™ RX is indicated for infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. It is not indicated for use in the neurovasculature.
*Abciximab, which is manufactured by Centocor and distributed by Eli Lilly under the trade name ReoPro®, is a platelet aggregation inhibitor mainly used during and after coronary artery procedures like angioplasty to prevent platelets from sticking together and causing thrombus (blood clot) formation within the coronary arteries. Abciximab is not indicated for IC delivery.
