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MEDRAD, INC. Announces European Approval and Launch of the Cotavance™ Drug Eluting Balloon With Paccocath® Technology
Date:5/16/2011

he treatment of PAD is demonstrated by the initiation of randomized clinical studies examining the safety and performance of the Cotavance product for treating diseased arteries above and below the knee. Two of these studies, EURO CANAL and DEFINITIVE AR (sponsored by ev3 Inc., a Covidien company, using Cotavance catheters), are expected to begin enrolling patients this summer. Additionally, the COPA CABANA and RIVER studies will be initiated at a later date. Collectively, these studies will enroll more than 640 patients in approximately 90 sites around the world. Information from these studies is intended to expand the scientific evidence of the Cotavance catheter and Paccocath technology and should provide valuable data for the clinical community toward optimum care for patients suffering from PAD.

In addition to initiating clinical studies, MEDRAD is continuing to advance the technology of Cotavance paclitaxel-eluting balloon angioplasty catheters. MEDRAD is pursuing CE Mark certification for the next-generation Cotavance product with innovations that include enhanced drug dose application, a new catheter platform and a full range of catheter sizes. This advanced technology is expected to be available in Europe in the second half of 2011. The company is also moving forward with the Investigational Device Exemption (IDE) process as one of the steps in gaining FDA approval for Cotavance product in the United States.

"The European approval of the Cotavance catheter, preparation for its next-generation product launch, and initiation of additional randomized clinical studies underscore our commitment to further advancing peripheral arterial disease treatment, particularly as restenosis remains a significant issue for many patients," said Jack Darby, vice president of MEDRAD Interventional. "As a key participant in the endovascular market, MEDRAD is pleased to offer this treatment even as we actively pursue additional innovations and clinical studies with
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