Medrad, Inc. Announces Supply Agreement with ev3 Inc. in Preparation for DEFINITIVE AR Pilot Trial
The DEFINITIVE AR (Anti-Restenosis) study is a prospective, multicenter, randomized pilot study evaluating the use of either the TurboHawk or SilverHawk Plaque Excision System followed by treatment with the Cotavance drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease. The pilot study will be led by Professor Thomas Zeller, MD, of Herz-Zentrum Bad Krozingen in Bad Krozingen, Germany and Professor Gunnar Tepe, MD, of Klinikum Rosenheim in Rosenheim, Germany.
"Drug-eluting balloons with Paccocath technology demonstrated encouraging safety and efficacy results in the THUNDER and FemPac trials," said Professor Tepe. "However, I believe that treatment outcomes could be improved by first removing plaque from the vessel with plaque excision prior to using a drug-coated balloon. The combination of TurboHawk or SilverHawk plaque excision followed by the use of the Cotavance balloon catheter may allow for enhanced drug uptake and an improved acute result and durability in the treated vessel."
The pilot study will evaluate up to 125 patients in Europe and is anticipated to begin in the second half of 2010. It is anticipated a global multicenter pivotal trial will follow the completion of the pilot study.
"We are pleased to announce this collaboration with MEDRAD and our plans for the DEFINITIVE AR pilot study," stated Robert Palmisano, ev3's president and chief executive officer. "Despite recent advances, restenosis remains a significant issue when treating peripheral arterial disease, especially in patients with complex disease such as diabetes and severely calcified lesions. We believe that the Hawk Plaque Excision Systems' unique ability to remove the plaque layer -- thereby achieving an optimal vessel lumen -- in combination with the Cotavance drug-eluting balloon catheter will provide valuable data for the clinical community in treating peripheral arterial disease."
"We are excited about the study of vessel preparation using Hawk plaque excision followed by MEDRAD's Cotavance drug-eluting balloon with Paccocath technology for patients with peripheral arterial disease," said Kraig McEwen, senior vice president of MEDRAD Interventional/Possis. "We are pleased to collaborate with ev3, a worldwide leader in atherectomy, on this important pilot study. We remain committed to expanding the scientific evidence of Cotavance and the Paccocath technology with additional clinical studies in the U.S. and Europe."
Bayer Schering Pharma AG is the owner of the Paccocath trademark and technology, a proprietary drug matrix applied to the balloon of an angioplasty catheter, and is developing it for market through Bayer affiliate, MEDRAD, under the brand name Cotavance™. When the balloon is inflated to dilate the narrowed vessel, paclitaxel is delivered directly to the diseased area. Clinical results to date show that using the Paccocath technology during an angioplasty procedure keeps the vessels open wider over time compared to standard angioplasty and published reports(1) of other standard therapies. MEDRAD is in the process of obtaining CE Mark certification and is preparing a US clinical trial to support FDA approval for its Cotavance product.
About ev3's Plaque Excision Systems
The SilverHawk and TurboHawk Plaque Excision Systems are catheter-based technology used primarily by vascular surgeons, interventional cardiologists and radiologists for the treatment of PAD. The devices use a small rotating blade to shave away plaque from inside the artery. As it is excised, the plaque collects in the tip of the device and then is removed from the patient, thereby restoring blood flow with minimal barotrauma and no permanent implant. Over 225,000 cases using the SilverHawk Plaque Excision System have been performed since the product first became available in 2003.
About ev3 Inc.
Since its founding in 2000, ev3 has been dedicated to developing innovative and breakthrough technologies for the endovascular treatment of peripheral vascular and neurovascular diseases. The company offers a comprehensive portfolio of treatment options, including the primary interventional technologies used today -- plaque excision systems, peripheral angioplasty balloons, stents, embolic protection devices, liquid embolics, embolization coils, flow diversion, thrombectomy catheters and occlusion balloons. More information about the company and its products can be found at http://www.ev3.net.
ev3, the ev3 logo, SilverHawk and TurboHawk are trademarks of ev3 Inc. and its subsidiaries, registered in the U.S. and other countries. All other trademarks and trade names referred to in this press release are the property of their respective owners.
(1)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.
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.
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.
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.
SOURCE MEDRAD, Inc.