Angiotech Pharmaceuticals has begun a US pivotal study examining the Vascular Wrap Paclitaxel-Eluting Mesh (Vascular Wrap). The multi-center study is designed to evaluate the safety and efficacy of the Vascular Wrap after surgical implantation with an ePTFE vascular graft in the upper extremity for hemodialysis vascular (AV) access. The combination of Angiotech’s Vascular Wrap with its VaxSys ePTFE vascular graft will be branded as the VaxSys Synergy product. The study enrolled its first patient in March 2007 in Winston-Salem, NC, and will involve approximately 530 patients at 50 centers in the US. It is expected that the duration of the study from first subject/first visit through to last subject/last visit will be approximately 24 months.
The VaxSys Synergy pivotal trial is a randomized, placebo-controlled, multi-center, two-arm study. The primary objective of the study is to demonstrate that the patency of the Vascular Wrap Paclitaxel-Eluting Mesh and the ePTFE graft is superior to the patency of the ePTFE graft alone within one year following vascular access surgery. Subjects will also be followed over a four-year period to confirm the long-term safety of the study device although the company anticipates filing for US regulatory approval after completion of the primary one year follow up period. Angiotech’s VaxSys Synergy product is designed for use in haemodialysis access and peripheral arterial bypass surgery.
The Vascular Wrap component is a biodegradable mesh implant incorporating Angiotech’s paclitaxel technology in a novel degradable biomaterial. The technology is designed with the goal of mitigating intimal hyperplasia formation caused by abnormal blood flow, thereby enhancing graft patency rates in AV-access patients as well as in peripheral bypass procedures.
In November 2006, Angiotech reported results from its European first-in-man study examining the safety and clinical performance of the Vascular Wrap when used to treat patients suffering from advanced peripheral arterial disease (PAD) in their lower limbs. Based on the strength of this two-year data, Angiotech submitted an application for CE mark approval for its Vascular Wrap paclitaxel-eluting mesh/ePTFE vascular graft combination product. Upon receipt of a CE mark, Angiotech would commence commercialization of its Vascular Wrap product in the EU and certain other countries outside of the US.