MEDRAD and B. Braun Melsungen AG Collaborate to Promote Breakthrough Medical Treatment for Cardiovascular Disease

WARRENDALE, Pa., Jan. 27 /PRNewswire/ -- MEDRAD, Inc. has entered into a co-marketing and trademark license agreement with B. Braun Melsungen AG (Melsungen, Germany) to promote the Paccocath® technology, a unique and clinically tested technology used to treat blocked vessels without stenting. The Paccocath technology has been shown in multiple clinical trials to keep the artery open wider (reduce late lumen loss) over time in patients with Peripheral Arterial Disease and Coronary Artery Disease (CAD).

The Paccocath technology will be used in both MEDRAD's and B. Braun's drug-eluting balloons. Under the agreement, B. Braun is permitted to use the Paccocath trademark in connection with promotion and marketing of its drug eluting balloon products. Both companies will also feature the Paccocath technology at various tradeshows, sponsored educational seminars and symposia, and on respective informational websites.

"We feel it is important to distinguish the positive clinical results of the unique Paccocath technology in the marketplace. This agreement allows us to do that in cooperation with B. Braun," said Kraig McEwen, senior vice president of MEDRAD Interventional/Possis. "We are delighted to be able to develop and market the Paccocath technology, which provides both companies the opportunity to offer a greater variety of products designed to improve patient treatment and outcomes," said Gerd Wacker, senior vice president from B. Braun, Vascular Systems.

The Paccocath technology is a proprietary drug matrix applied to the balloon of an angioplasty catheter. The matrix consists of paclitaxel, which has long been 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. The unique formula facilitates delivery of the paclitaxel to the surrounding tissue. Clinical results to date (including the THUNDER(1), PEPCAD(2), ISR(3), and FEMPAC(4) trials) show that using the Paccocath technology during an interventional procedure keeps coronary and peripheral vessels open wider over time compared to standard therapies(5).

Bayer Schering Pharma AG is the owner of the Paccocath trademark and technology and is developing it for market through Bayer affiliate, MEDRAD Inc. under the brand name Cotavance™. MEDRAD Inc. is in the process of obtaining CE Mark certification and is preparing a US clinical trial to support FDA approval for its Cotavance product.  

B. Braun has licensed the Paccocath technology for use on its SeQuent® Please(6) -- Drug Eluting Balloon Catheter for the treatment of narrowing of the coronary arteries. SeQuent® Please recently received the CE mark and is now commercially available in all those countries which accept the CE certificate.

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 safe treatment of cardiovascular disease, magnetic resonance-compatible accessories and equipment services. The company's world headquarters is near Pittsburgh, Pennsylvania, in the United States. MEDRAD is a business of Bayer Medical Care. 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 subsidiary of Bayer AG, 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. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

About B. Braun

B. Braun is a leading manufacturer of infusion therapy and pain management products with an environmentally-friendly focus. Guided by the company's "Sharing Expertise®" philosophy, B. Braun addresses the critical issues of infection prevention, medication safety and environmental responsibility by promoting best practices that help clinicians reduce medication errors, prevent healthcare-acquired infections (HAIs) and achieve sustainability objectives.

Consistently recognized by Frost & Sullivan and KLAS for its medical technology and support services, B. Braun employees share their knowledge with colleagues and customers to improve working processes in hospitals and medical practices and to enhance the safety of patients and healthcare professionals. For more information, call 800-227-2862, e-mail us at [email protected] or visit B. Braun at www.bbraunusa.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) 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.

(2) 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.

(3) 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.

(4) 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.

(5) 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.

(6) SeQuent® Please is not approved or available for sale in the United States.

SOURCE MEDRAD, Inc.