Atrium Medical Corporation Announces Release of the Final Results

HUDSON, NH--(Marketwire - November 05, 2009) - Atrium Medical Corporation is proud to announce the release of the final results of the “COCTAIL Study,” a clinical study comparing local administration of an anti-platelet medication with the company’s proprietary infusion balloon technology. Dr. Francesco Prati of San Giovanni Hospital and the European Imaging Laboratory in Rome, Italy presented the results of this study at the recent TCT (Transcatheter Cardiovascular Therapeutics) meeting held in San Francisco, California. The final results demonstrated that super selective local intracoronary infusion of an anti-platelet medication known as abciximab* through the Atrium® ClearWay™ RX Local Therapeutic Infusion Catheter significantly reduced occluded coronary thrombus burden as measured by Optical Coherence Tomography (OCT) while infusion of the same dose of medication through a traditional open-ended guide catheter did not.

This first of its kind coronary occlusion study is a multi-centered, randomized, single blinded, controlled clinical trial comparing local coronary administration of the drug abciximab through a guide catheter compared with local coronary administration of abciximab using Atrium’s novel infusion balloon catheter. The primary objective is to verify whether local intracoronary delivery (IC) with Atrium’s ClearWay™ RX infusion balloon catheter is capable of reducing thrombus burden, confirmed by OCT imaging analysis, as compared to traditional IC guide catheter infusion (no infusion balloon). The secondary objective is to address whether the administration of abciximab by IC ClearWay™ RX, as compared to IC guide catheter delivery, can improve macro and micro circulation post intervention by measuring corrected TIMI Frame Count (cTFC) and Myocardial Blush Grade imaging scores via angiography.

The study enrolled a total of 50 patients. The final results presented were for 41 patients who entered the final analysis: 20 in the ClearWay™ RX group, and 21 in the Guide Catheter group.

The primary endpoint demonstrated infusion balloon delivery of the anti-platelet medication abciximab through the Atrium ClearWay™ RX catheter significantly reduced the thrombus volume or thrombus burden in the coronary by over 34% (p = 0.0007) while local guide catheter infusion only reduced the thrombus burden by 4% (p = ns). There was also statistically significant improvement in the corrected TIMI Frame Count (cTFC) in the ClearWay™ RX infusion group compared to the guide catheter infusion group, indicating better patient outcomes by use of the Atrium infusion balloon technology. The ClearWay™ RX infusion group had an average cTFC of 15.29 versus 21.07 for the guide catheter infusion group (p < 0.05). The ClearWay™ RX infusion group had more patients with improvement of blood flow to the heart muscle, with the highest TIMI score as possible at 3, which is an important measurement for heart muscle perfusion following an acute myocardial infarction or heart attack.

The overall Myocardial Blush Grade scores in all ClearWay™ RX patients also showed a positive improvement trend, but the blush grade score data was not statistically significant. Another interesting finding from the final study results was the fact the Atrium ClearWay™ treatment group demonstrated a lower percent diameter stenosis of 5.9% vs. 11.2% for the Guide Catheter group (p = 0.022) at immediate post-procedure angiography review, demonstrating further evidence of efficacy in this study for the ClearWay™ device.

These findings are considered to be very exciting for the management of acute myocardial infarction (AMI) patients. This novel treatment strategy with Atrium’s infusion balloon technology for use in myocardial infarction (MI) patients will be further tested in a large, multi-centered, randomized, controlled trial known as INFUSE AMI. Principal Investigator Gregg Stone, MD from New York and Co-Principal Investigator C. Michael Gibson, MD from Boston will report their initial findings in the fall of 2010.

Disclaimer: ClearWay™ RX is manufactured & distributed by Atrium Medical Corporation worldwide and is indicated for localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature.

*Abciximab (ReoPro® - Lilly®) is indicated as an adjunct to PCI for the prevention of cardiac ischemic complications: In patients undergoing PCI and in patients with UA not responding to conventional medical therapy when PCI is planned within 24 hours. It is not indicated for intracoronary delivery.

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. 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 Google® Atrium Medical, and visit us on the web at www.atriummed.com.