ev3 Inc 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 of Herz-Zentrum Bad Krozingen in Bad Krozingen, Germany and professor Gunnar Tepe 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(TM). 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.

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.

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.

Medrad develops, markets and services medical devices used to diagnose and treat disease.