MEDRAD, INC. Announces European Approval and Launch of the Cotavance™ Drug Eluting Balloon With Paccocath® Technology

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 the 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 the Cotavance product globally."

MEDRAD Interventional is comprised of MEDRAD, INC. and Possis Medical, two pioneering innovators of endovascular and interventional cardiology products. 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. Paccocath, Cotavance, and Ultravist are trademarks of Bayer Schering Pharma AG and are used under license by MEDRAD, INC.

About MEDRAD, INC.

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.

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 16.913 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.

Forward-looking statements

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

(1) Cotavance is not approved or available for sale in the United States.

(2) Tepe G et al. 2008. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 14; 358 (7):689-99.

(3) Unverdorben M. et al. 2009. Paclitaxel-Coated Balloon Catheter versus Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis. Circulation. 2009;119:2986-2994.

(4) Scheller B. et al. 2008. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 97(10):773-81.

(5) Werk, M. et al. 2008. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 23;118(13):1358-65.

(6) Duda SH, Bosiers M, Lamme J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006; 13: 701–710.

SOURCE MEDRAD, INC.

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