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Medrad receives CE Mark for Cotavance

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Launch of next generation of Cotavance paclitaxel coated balloon angioplasty catheter with Paccocath® technology / New Cotavance catheter platform includes improved paclitaxel coating process and dose control
Leverkusen/Munich, September 12, 2011 – Medrad, Inc., a business of Bayer HealthCare, today announced it has received CE Mark for its next generation Cotavance® Paclitaxel Coated Balloon Angioplasty Catheter with Paccocath® technology. Currently available and marketed through the Medrad Interventional business unit, the next generation Cotavance balloon catheter is designed to incorporate innovations that include an improved paclitaxel coating process for controlled drug dosing and a new catheter platform with a full range of catheter sizes. The announcement was made in conjunction with the annual congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Munich, 10-14 September 2011.

The Cotavance balloon 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 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.

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 Ultravist® 370, a radiologic contrast agent. When the balloon is inflated to dilate the narrowed vessel, paclitaxel is delivered directly to the diseased area. Bayer Pharma AG is the owner of the Paccocath technology.

“Our goal is to continue to provide compelling peripheral arterial intervention technology that enables physicians to advance the treatment of PAD and improve patient outcomes,” said Jack Darby, Senior Vice President of Medrad Interventional. “We believe this new Cotavance platform represents a state-of-the-art option for treating PAD patients, from routine to difficult cases.”

In addition to the advances in the Cotavance catheter technology, Medrad Interventional continues to invest in rigorous, randomized studies to better understand treatment options and indications. These studies include the recently announced first-patient enrolled in the ev3 DEFINITIVE AR study using Cotavance balloon catheters (representing the first research application of the next generation Cotavance catheter) sponsored by Covidien, as well as three additional randomized clinical studies including EURO CANAL, COPA CABANA (physician‐sponsored study using Cotavance) and RIVER. Together these studies will involve approximately 90 centers worldwide and include more than 700 patients with the goal of expanding scientific evidence of the Cotavance balloon catheter with Paccocath technology and providing valuable data for the clinical community toward optimized care for patients suffering from PAD.

About Medrad
The cardiovascular products of Medrad, Inc. were merged with the endovascular products of Possis Medical to form Medrad Interventional. Focused on the research and development of advanced technologies, Medrad Interventional designs, manufactures and markets devices that enable interventional physicians to better see and treat coronary and vascular disease.
Medrad, Inc. develops, markets and services medical devices used to diagnose and treat disease. Its product offerings include fluid injection systems for radiology and cardiology, endovascular devices for the treatment of cardiovascular disease, magnetic resonance-compatible accessories and equipment services. Medrad is a two-time recipient of the Malcolm Baldrige National Quality Award, the top honor a U.S. company can receive for quality and business excellence (2003 and 2010). The company’s world headquarters is near Pittsburgh, Pennsylvania, in the United States. Medrad is a business of Bayer HealthCare. More company information is available at www.medrad.com.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.9 billion (2010), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.

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