Medrad Interventional/Possis and device company ev3 have entered a supply agreement for use of the Cotavance peripheral drug-eluting balloon angioplasty catheter with Paccocath technology in a European clinical trial looking to treat patients with peripheral arterial disease (PAD).
Under the terms of agreement, Cotavance will be studied in combination with ev3’s SilverHawk and TurboHawk Plaque Excision Systems in the DEFINITIVE AR (anti-restenosis) --a pilot study conducted in Europe.
The DEFINITIVE AR clinical trial will enroll 125 patients in Europe to assess use of ev3’s TurboHawk or SilverHawk plaque excision systems followed by treatment with Medrad’s Cotavance drug-eluting balloon catheter versus the Cotavance balloon catheter alone to assess its ability to treat PAD.
Warrendale, Pa.-based Medrad said that the trial is set to begin in the second half of 2010 and will be led by Thomas Zeller, PhD, of the Herz-Zentrum Bad Krozingen and Gunnar Tepe, MD, of Klinikum Rosenheim, both in Germany.
Medrad is in the process of receiving a CE mark of approval for Cotavance and is looking to perform a U.S. clinical trial for FDA approval; however, prior clinical trials have shown that its Paccocath technology opens the vessels wider during PCI procedures, the company said.
"Drug-eluting balloons with Paccocath technology demonstrated encouraging safety and efficacy results in the THUNDER and FemPac trials," said 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."