Atrium Announces Positive Results of INFUSE-AMI Clinical Trial During the American College of Cardiology's 61st Annual Scientific Session

HUDSON, N.H., March 25, 2012 - Atrium Medical Corporation, a business unit of MAQUET Cardiovascular, today announced the results of the INFUSE-AMI study (Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anterior ST Segment Elevation Myocardial Infarction (MI)), a multi-center, multi-national clinical trial conducted to determine the optimal treatment strategy for patients with an acute anterior wall myocardial infarction with ST segment elevation (STEMI).

The study findings demonstrated that in patients with large anterior STEMI presenting early after symptom onset and undergoing percutaneous coronary intervention (PCI), intracoronary administration of the platelet inhibitor abciximab delivered directly to the heart attack lesion site via Atrium's ClearWay RX Local Therapeutic Infusion Catheter significantly reduced the size of the MI at 30 days (primary endpoint). The data were presented today in a late-breaking session at the American College of Cardiology's (ACC) 61st Annual Scientific Session in Chicago and published online in the Journal of the American Medical Association (JAMA).

"In patients who have suffered a heart attack, recovery of the heart muscle is often suboptimal despite restoration of blood flow. INFUSE-AMI was uniquely designed to be able to demonstrate whether therapies are able to reduce infarct size in patients with large heart attacks, those with the greatest clinical need," said Dr. Gregg W. Stone, principal investigator of INFUSE-AMI and professor of medicine and director of cardiovascular research and education at New York-Presbyterian Hospital and Columbia University Medical Center. "In these patients, the platelet inhibitor abciximab delivered to the infarct lesion site via the ClearWay RX Infusion Catheter resulted in a significant reduction in infarct size at 30 days. However, manual aspiration of the blood clot did not reduce infarct size."

INFUSE-AMI Study Design and Results
The INFUSE-AMI trial, a prospective, randomized, single-blind trial conducted at 37 clinical sites in the U.S. and five European countries enrolled 452 patients who presented within four hours of a STEMI involving the anterior wall of the heart. Study subjects were randomized to one of four study arms, which assessed four different ways to treat the thrombus (blood clot) causing the patient's heart attack:

• Intracoronary infusion of abciximab* via the ClearWay RX Local Therapeutic Infusion Catheter with thrombus aspiration

• Intracoronary infusion of abciximab via ClearWay RX without thrombus aspiration

• Thrombus aspiration only

• No abciximab infusion and no thrombus aspiration but current standard of care only (i.e., traditional PCI, often with a stent)

The goal of the trial was to help identify which treatment strategy could provide better patient outcomes with the goal of reducing the infarct size during a heart attack and restoring flow in the infarct-related artery and microvasculature in the heart muscle without an increase in major and minor bleeding. Study endpoints included impact on infarct size at 30 days as measured by cardiac MRI, ST segment resolution, myocardial perfusion, impact on thrombus burden, and outcomes on bleeding.

Results showed that patients randomized to local therapeutic infusion of intracoronary abciximab with ClearWay RX compared to no abciximab had a significant reduction in 30-day infarct size (15.6 percent relative reduction). Patients randomized to local infusion of intracoronary abciximab also demonstrated a significant reduction in absolute infarct mass (22.1 percent relative reduction).

In contrast, manual aspiration thrombectomy did not significantly reduce infarct size. No significant differences in any of the major safety or efficacy endpoints were present between the randomized groups at 30 days. Post hoc analysis revealed median infarct size was lowest in the intracoronary abciximab plus aspiration group compared with the other groups.

The INFUSE-AMI trial was led by the Cardiovascular Research Foundation (CRF) in New York. Dr. Stone was the principal investigator and Dr. C. Michael Gibson, chief of clinical research at Beth Israel Deaconess Medical Center/Harvard Medical School in Boston, served as co-principal investigator. It was sponsored and funded by Atrium Medical Corporation, Medtronic and The Medicines Company.

About the Atrium ClearWay RX Local Therapeutic Infusion Catheter

The ClearWay RX Local Therapeutic Infusion Catheter is an extraordinarily thin, microporous PTFE balloon mounted on a .014" rapid exchange catheter. The ClearWay RX catheter 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 balloon controllably engages the vessel wall to gently and atraumatically occlude blood flow during infusion thus providing drug concentrations hundreds of times greater at the site of local delivery than traditional systemic drug administration. 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 10 to 50 mm.

For more information please visit www.atriummed.com.

image description image description
Other News Items