MEDRAD, INC. It announces the approval of the liberating drug Cotavance Tm ball in Europe.

– MEDRAD, INC. announced the approval and European launch of the liberating ball of drug Cotavance (TM) technology Paccocath r

-additional clinical studies and progress technologies for catheter Cotavance in progress

Warrendale, Pennsylvania, may 2011.- MEDRAD, INC., a business of Bayer HealthCare, announced on Tuesday it has received CE mark for its Cotavance (TM) Paclitaxel Coated Balloon Angioplasty Catheter with Paccocath (R) technology. Cotavance catheter used gastrostomies interventions for the treatment of arterial disease peripheral (EAP) and is approved for dilation balloon injury estenóticas in the iliac arteries and infrainguinal while paclitaxel is applied to the vessel wall to inhibit the restenosis. MEDRAD Interventional has begun to sell their Cotavance catheter in countries where has already received regulatory approval, including certain countries in Europe and the Middle East.”(1) The statement was made in conjunction with the Congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) in Paris.

“”Effective treatments for peripheral arterial disease continue to be a major medical challenge,” said the Professor Gunnar Tepe, MD, Klinikum Rosenheim, Rosenheim, Germany. “The recent European adoption of catheter Cotavance offers new innovative approaches to improve patient outcomes.” “More importantly, the only clinical long-term positive results to date with drug eluting balloon have used technology Paccocath to keep more open coronary and peripheral vessels for longer compared to standard therapies”.(2), (3), (4), (5), (6)

Paccocath technology is a patented drug matrix applied to the balloon of a catheter for angioplasty. The matrix consists of paclitaxel, used in drug-eluting stents of drug to treat the disease cardiovascular and radiological contrast, Ultravist r 370 agent. When the balloon is inflated to dilate the vessels estrechados, paclitaxel is administered directly to the diseased area. Bayer Schering Pharma AG is the owner of the Paccocath technology and MEDRAD Interventional develops and markets under the brand Cotavance name.

The commitment of MEDRAD forward PAD treatment shows by the beginning of randomised trials that examined the safety and performance of the product of Cotavance to treat sick above and below the knee artery. Two of these studies, EURO channel and DEFINITIVE AR (sponsored by ev3 Inc., a company Covidien, using catheters Cotavance), will start to recruit patients this summer. In addition, COPA CABANA and RIVER studies will be launched at a later date. Collectively, these studies recruit more than 640 patients in approximately 90 sites around the world. Information from these studies will expand the scientific evidence of Cotavance catheter and Paccocath technology and they should provide valuable data for the clinical community to optimal care for patients with EAP.

In addition to start trials, MEDRAD continues to advance the technology of Cotavance paclitaxel eluting balloon angioplasty catheters. MEDRAD search CE certification for the product Cotavance of next-generation innovations that include the implementation of drug dose improved, a new platform of catheter and a full range of sizes of catheter. This advanced technology will be available in Europe in the second half of 2011. The company also advances with the clinical Device Exemption (IDE) process as one of the steps to obtain approval from the FDA for the product of Cotavance in United States.

“The European approval of Cotavance catheter, preparation for its next generation product release and the start of further randomised clinical studies highlight our commitment to advancing the treatment of peripheral arterial disease, particularly while the restenosis remains a major problem for many patients”, said Jack Darby, Vice President of MEDRAD Interventional. “As a main participant in the endovascular market, MEDRAD is pleased to offer this treatment even when we are actively pursuing further innovations and trials with the product Cotavance to level world.”

MEDRAD Interventional is formed by MEDRAD, INC. and Possis Medical, two innovative pioneers in cardiology endovascular products and intervencional. Focusing on research and development of advanced technologies, MEDRAD Interventional designs, manufactures and sells devices that allow the interventionist doctors see better 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, sells and delivers medical devices used to diagnose and treat the disease. Their product offerings include fuel injection of fluids for Radiology and cardiology devices Endovascular for the safe treatment of cardiovascular disease, accessories compatible with magnetic resonance imaging and equipment services. MEDRAD has received twice the Malcolm Baldrige National Quality Award, the highest honor that an American company can receive quality and business excellence (2003-2010). The company’s global headquarters is near Pittsburgh (Pennsylvania, USA.)(UU.). MEDRAD is a business of Bayer Medical Care.

bayer healthcare

the Bayer Group is a global company with skills key in the fields of health, nutrition and materials of high technology Bayer HealthCare, a subsidiary of Bayer AG with annual sales of 16.913 million euros (2010), is one of the leaders of the world and innovative in the industry of healthcare and medical based products in Leverkusen (Germany). The company combines the global activities of the divisions animal health, attention to the consumer, health care and pharmaceutical products. Bayer HealthCare aims to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55.700 employees (December 31, 2010) and is represented in over 100 countries.

Referencia:

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

(2) Tepe G et to the. 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 to the. 2009 Paclitaxel-Coated Balloon Catheter versus Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis. Circulation. 2009; 119: 2986-2994.

(4) B. Schaller et to the. 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 to the. 2008 Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 23; 118 (13): 1358-65.

(6) Doubt SH, Bosiers M, Lamme J, Scheinert D, Zeller T, olive V, Tielbeek, Anderson J, Wiesinger B, Tepe G, Lansky, Jaff MR, Mudde C, H Tielemans, 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.