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

WARRENDALE, Pa., May 17, 2011 /PRNewswire/ -- MEDRAD, INC., a business of Bayer HealthCare, today announced it has received CE Mark for its Cotavance™ Paclitaxel Coated Balloon Angioplasty Catheter with Paccocath® technology. The Cotavance catheter is used in percutaneous interventions for the treatment of peripheral arterial disease (PAD) and is approved for balloon dilation of stenotic lesions in the iliac and infrainguinal arteries while applying paclitaxel to the vessel wall to inhibit restenosis. MEDRAD Interventional has started selling its Cotavance catheter in countries where it has already received regulatory approval, including select European and Middle East countries.(1) The announcement was made in conjunction with the Congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) in Paris.

"Effective treatments for peripheral artery disease continue to be a major medical challenge," said Professor Gunnar Tepe, MD, of Klinikum Rosenheim in Rosenheim, Germany. "The recent European approval of the Cotavance catheter offers an innovative new approach for improving patient outcomes. Importantly, the only positive long-term clinical results to date with drug-eluting balloons have used the Paccocath technology to successfully keep coronary and peripheral vessels open wider over time compared to standard therapies."(2),(3),(4),(5),(6)

The Paccocath technology is a proprietary drug matrix applied to the balloon of an angioplasty catheter. The matrix consists of paclitaxel, long used in drug-eluting stents to treat cardiovascular disease, and a radiologic contrast agent, Ultravist® 370. When the balloon is inflated to dilate the narrowed vessel, paclitaxel is delivered directly to the diseased area. Bayer Schering Pharma AG is the owner of the Paccocath technology and MEDRAD Interventional is developing and marketing it under the brand name Cotavance.

MEDRAD's commitment to further advancing t
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