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New data show CAS in clinical practice has comparable MAE rate with pivotal sapphire trial

Cordis Endovascular, a division of Cordis Corporation, announced today that preliminary results of its CASES peri-approval study (CASES-PMS) showed that high surgical-risk patients treated with carotid artery stenting (CAS) had identical 30-day major adverse event (MAE) rates with that of patients treated with CAS in the pivotal SAPPHIRE study. The data, which were presented today at the American College of Cardiology Scientific Sessions, showed an MAE rate of 4.8 percent (62/1279) among patients treated with CAS in CASES-PMS compared with 4.8 percent (8/167) of CAS-treated patients in the randomized arm of the SAPPHIRE trial.

CASES-PMS is a multi-center, prospective, single arm open-label peri-approval study designed to assess the outcomes of stenting with Cordis' PRECISE* Nitinol Self-Expanding Stent, and ANGIOGUARD XP* Emboli Capture Guidewire System in the treatment of obstructive artery disease in relation to the outcomes of the pivotal SAPPHIRE study. The study's primary objective is to demonstrate that outcomes in a peri-approval setting, including use of a detailed training program in CAS for physicians not experienced in CAS, allow outcomes that are similar to those obtained in the pivotal trial setting.

"These initial findings are very important because they both corroborate the findings of the landmark SAPPHIRE study, and demonstrate that formalized training in carotid stenting allows physicians from multiple specialties with prior endovascular experience to perform carotid stenting and obtain outcomes as good as the experts that performed the clinical trials," said Dennis Donohoe, M.D., Vice President, Worldwide Regulatory and Clinical Affairs, Cordis Corporation. "The outcomes in this study are an important additional set of data supporting the generalizability of results from the SAPPHIRE trial, the only randomized clinical trial of carotid stenting compared to carotid endarterectomy."

Cordis Endovascular initiated CASES,
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Contact: Steven Cooper
steven.cooper@edelman.com
917-301-7566
Edelman Public Relations
13-Mar-2006


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