Medrad's Cotavance Drug-Eluting Balloon Receives CE Mark

May 17, 2011—Medrad, Inc. (Warrendale, PA) announced that it has received CE Mark approval 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.

At the EuroPCR 2011 conference in Paris, Medrad announced it has started selling its Cotavance catheter in markets where the device has already received regulatory approval, including select European and Middle East countries.

“Effective treatments for PAD continue to be a major medical challenge,” commented Professor Gunnar Tepe, MD. “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.”

According to Medrad, Paccocath technology is a drug matrix applied to the balloon of an angioplasty catheter. The matrix consists of paclitaxel and a radiologic contrast agent, Ultravis 370. Bayer Schering Pharma AG (Berlin, Germany) is the owner of the Paccocath technology, and Medrad Interventional is developing and marketing it under the brand name Cotavance. Cotavance is not approved or available for sale in the United States, the company advised.

Medrad also noted 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, are expected to begin enrolling patients this summer. DEFINITIVE AR is sponsored by Covidien (Mansfield, MA) to study its SilverHawk and TurboHawk plaque excision systems using Cotavance catheters.

Additionally, Medrad's COPA CABANA and RIVER studies will be initiated at a later date. These studies will collectively 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 PAD patients, the company stated.

Finally, Medrad stated that it is pursuing CE Mark approval for the next-generation Cotavance product, which the company expects to be available in Europe in the second half of 2011, and it is also moving forward with the investigational device exemption process as one of the steps in gaining Food and Drug Administration approval for Cotavance in the United States.