Angiotech starts EU trial for broader indication of Vascular Wrap
This article was originally published in Clinica
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.