Vascular Wrap™ paclitaxel-eluting mesh surgical implant (“Vascular Wrap”)

The Vascular Wrap™ surgical mesh is intended to treat complications associated with vascular graft implants in peripheral vascular disease and hemodialysis patients.

The Vascular Wrap surgical mesh is currently undergoing human clinical trials in the EU, where 109 patients have been enrolled in a study examining the safety of the Vascular Wrap surgical mesh in patients with peripheral vascular disease. We are currently evaluating the data from this study in order to prepare for a possible CE Mark filing. Should we file for a CE Mark, and subsequently receive CE Mark approval from the EU regulatory authorities, we would, together with our partner Edwards Lifesciences, be able to market and sell the Vascular Wrap surgical mesh in the EU. During the quarter we announced positive results from a preclinical study to evaluate the efficacy of the Vascular Wrap surgical mesh on inhibiting the growth of scar tissue (neointimal hyperplasia) inside a synthetic vascular graft in an animal model of dialysis access failure. In this study, neointimal hyperplasia was reduced by a minimum of 87.6% in animals who received a Vascular Wrap surgical mesh compared with animals who received no Vascular Wrap surgical mesh.

Based upon this preclinical data, we will soon begin to enroll a clinical trial in the United Kingdom to assess the effectiveness and safety of the Vascular Wrap surgical mesh in patients receiving a Lifespan® synthetic vascular graft for the purposes of providing hemodialysis access. Specifically, the trial seeks to determine that hemodialysis patients who receive the Vascular Wrap surgical mesh / Lifespan graft combination experience fewer graft failures than those patients that receive the Lifespan graft alone. We also intend to conduct a similar trial in the U.S. Both trials are expected to be about 24 months in duration, with enrollment taking approximately one year. The goal of the studies is to provide Angiotech with sufficient data to submit to regulatory authorities for approval to market the Vascular Wrap surgical mesh for use in hemodialysis patients in the United States and the EU.