Angiotech starts EU trial for broader indication of Vascular Wrap
This article was originally published in Clinica
Executive Summary
Pressing on with efforts to expand the potential market for its Vascular Wrap - a paclitaxel-eluting mesh - Angiotech Pharmaceuticals has begun a European trial of the device in dialysis patients with end-stage renal disease. The technology is currently awaiting EU approval for use in advanced peripheral arterial disease of the lower limbs. The 198-patient EU trial is assessing its use after surgical implantation with an ePTFE vascular graft in the upper extremity for haemodialysis vascular access; a control group of patients will receive the standard of care - an ePTFE vascular graft alone. A pivotal trial in the US is also underway for assessing the AV access indication. The Vancouver, Canada-based firm expects to use the EU trial data along with the US trial results to support a CE-mark submission.