Covidien has commenced patient enrollment in the ev3 Definitive anti-restenosis (AR) study, which is designed to address the challenge of restenosis in patients with peripheral arterial disease (PAD).
The study will look at the effects of treating a diseased vessel with plaque excision prior to the use of a drug-coated balloon.
The study will evaluate the use of either the TurboHawk or SilverHawk Plaque Excision System followed by treatment with the Cotavance drug-coated balloon catheter versus treatment with the Cotavance device alone in PAD patients.
The Cotavance device used in the study is the next generation catheter platform with an enhanced drug coating process, currently pending European regulatory review.
Thomas Zeller of Herz-Zentrum Bad Krozingen in Germany said treating the vessel with plaque excision and removing the calcium, prior to the application of the drug-coated balloon, may enhance its effect.
"If this proves to be the case, plaque excision followed by drug-coated balloons may become a key strategy for achieving long-term results when treating long, diffuse calcified plaque build-up in the leg," Zeller said.
Covidien Vascular Therapies president Joe Woody said Definitive AR is the third study in the Definitive Trial series, generating clinical evidence to confirm the effectiveness of plaque excision with the TurboHawk/SilverHawk System.