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Unique Cardiovascular Treatment Readied for Global Market: Proprietary Paccocath(R) Technology is the Only Drug Eluting Balloon with Clinical Data
Date:5/18/2009

York) and Gary Ansel, M.D. of Riverside Methodist Hospital (Columbus, Ohio) have been selected as the co-primary investigators for the U.S. clinical peripheral pivotal trials to achieve FDA approval for Cotavance. "The safety and efficacy outcome of the THUNDER study from Europe is a great starting point for US clinical trials with the Cotavance product. I am very hopeful that this technology will provide new and better treatment options for patients with claudication," said Dr. Gray.

"Paccocath is in the unique position of being the only drug eluting balloon technology with positive clinical science results. The THUNDER and FEM studies, which used the Paccocath technology exclusively, show its potential efficacy and safety in peripheral applications," said Professor Gunnar Tepe, MD, of Klinikum Rosenheim in Rosenheim, Germany. The successful clinical results to date achieved through the application of the Paccocath technology have encouraged others to market coated balloons, but without the Paccocath technology, none have proven clinical science benefits. According to Dr. Ansel, "The concept of drug eluting balloons is very attractive, but there may be much more to creating a clinical effect than just putting a drug onto an angioplasty balloon. What appears to make this technology unique is the addition of the Ultravist(R) to the Paclitaxel, which seems to allow for significant drug uptake in the treated vessel."

Bayer Schering Pharma AG (Berlin, Germany) is the owner of the Paccocath technology and is developing it for market through Bayer affiliate, MEDRAD, Inc. Kraig McEwen, senior vice president of MEDRAD Interventional/Possis said, "We are working to further the scientific evidence of the Paccocath technology with additional clinical studies in the U.S. and Europe. These studies are focused on achieving FDA clearance for peripheral indications and will help us understand patient outcomes in a variety of treatment situatio
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