Atrium Medical Announces 1-Year Results of the INFUSE-AMI Trial

May 3, 2013—Atrium Medical Corporation (Hudson, NH), a business unit of Maquet Cardiovascular (Wayne, NJ), announced the 1-year results of the INFUSE-AMI (Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) trial. INFUSE-AMI Principal Investigator Gregg Stone, MD, presented the findings in March 2013 at the 62nd annual scientific session of the American College of Cardiology in San Francisco, California.

According to the company's press release, INFUSE-AMI's primary endpoint was a reduction in infarct size measured by cardiac magnetic resonance imaging at 30 days in patients who were treated with intralesional ClearWay RX/abciximab versus those who did not receive this therapy. The 30-day primary endpoint was achieved, and patients who were treated with intralesional ClearWay RX/abciximab experienced a statistically significant relative reduction in infarct size of 16%. Additionally, patients in the ClearWay RX/abciximab arm showed a favorable trend in new onset of severe heart failure in comparison to patients who did not receive this treatment.

The company advised that clinical findings between 30 days and 1 year for patients who received intralesional ClearWay RX/abciximab were strongly associated with better outcomes, including significantly lower mortality rates and reduced major adverse cardiac and cerebral events compared to patients who did not receive ClearWay RX/abciximab.

Atrium Medical's announcement noted that the investigators also observed that all mortality occurred in patients with an infarct size > 17.1% (the median infarct size in the INFUSE-AMI trial was 17.2%). The median infarct size for patients treated with ClearWay RX/abciximab was 15.1%, whereas the median infarct size for patients who received an alternative treatment was 17.9%. The INFUSE-AMI data show a relationship between infarct size and mortality. These clinical findings correlate with other published studies and could explain some of the improved results in patients receiving intralesional abciximab via the ClearWay RX drug-delivery balloon, stated the company.

In the Atrium Medical press release, the trial's Coprincipal Investigator, Michael Gibson, MD, commented, “ClearWay offers the interventionists a reproducible, on-the-table treatment option for the preservation of heart muscle, resulting in reduced clinical events, and was associated with a mortality reduction in this mechanistic study.”

Atrium Medical's ClearWay RX local drug delivery balloon catheter is a thin, microporous polytetrafluoroethylene balloon mounted on a 0.014-inch, rapid-exchange catheter has both US Food and Drug Administration 510(k) clearance and European CE Mark approval for the delivery of therapeutic and diagnostic agents in the coronary and peripheral vasculature. The ClearWay RX balloon atraumatically occludes blood flow during local infusion, thus maximizing the therapeutic agent's concentration and residence time, enhancing the desired therapeutic effect.

ClearWay RX is available in 1- to 4-mm balloon diameters and in balloon lengths ranging from 10 to 50 mm. As of October 1, 2012, the ClearWay RX drug-delivery balloon was added to the American College of Cardiology guidelines as an approved device meeting the criteria for “door-to-balloon” time, stated the company's press release.