Angiotech’sVascular Wrap cuts amputation incidence
This article was originally published in The Gray Sheet
Executive Summary
A single-blind study of 109 patients at nine clinical centers in Europe finds that the control group had about a 19% higher probability of amputation compared with the group treated with Angiotech's Vascular Wrap. The paclitaxel-eluting mesh prevents scar formation that often leads to graft failure in patients with end-stage peripheral arterial disease, according to the firm. Angiotech expects the product to launch late this year in the UK and Germany after it gains a CE mark. FDA designated the combination product as a device in 2005, which could result in a quicker regulatory timeline than if it had been designated a drug, Angiotech says (1"The Gray Sheet" Jan. 2, 2006, p. 4). The firm is enrolling patients in its PREVAIL U.S. pivotal trial to assess the product in end-stage renal patients undergoing hemodialysis...