PLYMOUTH, Minn., April 8, 2010 (GLOBE NEWSWIRE) -- ev3 Inc. (Nasdaq:EVVV) today announced the initiation of a supply agreement with MEDRAD Interventional™/Possis®. Under terms of the agreement, MEDRAD will make available their Cotavance™ peripheral drug-eluting balloon angioplasty catheter with Paccocath® technology for study in combination with ev3's SilverHawk® and TurboHawk™ Plaque Excision Systems for use in the DEFINITIVE AR European pilot study for treating lower extremity peripheral arterial disease (PAD).
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 reports1 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.
1Duda 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.
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.
Forward Looking Statements
Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the success, design, expected patient enrollment and other features of ev3's DEFINITIVE AR trial, the efficacy, performance and success of the SilverHawk and TurboHawk plaque excision systems, future regulatory submissions and other statements identified by words such as "expect," "anticipate," "will," "may," "believe," "could," or words of similar meaning. Such forward-looking statements are based upon the current beliefs and expectations of ev3's management and are inherently subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties include, but are not limited to, in no particular order: the success of clinical testing and new products, delays in regulatory approvals and introduction of new products and market acceptance of new products. More detailed information on these and additional factors which could affect ev3's operating and financial results is described in ev3's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K. ev3 urges all interested parties to read these reports to gain a better understanding of the many business and other risks that ev3 faces. Additionally, ev3 undertakes no obligation to publicly release the results of any revisions to these forward-looking statements to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.