Maquet Cardiovascular announced on 25 May 2010 enrolment of the first patient in FINEST (Fusion vascular graft, Fusion Vascular Graft with Bioline and Exxcel Soft ePTFE). This prospective, randomised, single-blind, three-arm, parallel group, multicentre study is evaluating the safety and efficacy of Maquet’s investigational Fusion Vascular Graft and Fusion Bioline Vascular Graft, compared with its commercially available Exxcel Soft ePTFE Vascular Graft in peripheral artery bypass surgery.
The first patient was enrolled by Wei Zhou at VA Palo Alto Health Care System in Palo Alto, USA.
“As many as 8 million Americans are affected by peripheral artery disease and, in severe cases, require surgery in which a vein from another part of the body or a vascular graft is attached above and below the blocked area to detour blood around the blocked spot,” said principal investigator Alan Lumsden, vascular surgeon, Methodist Hospital in Houston, USA. “The FINEST trial will provide important information about the safety and efficacy of Fusion Vascular Grafts, which could provide an important new surgical option for these patients.”
The FINEST study is expected to enrol 300 patients at up to 20 clinical sites in the United States over the next six to 12 months. The study will include patients with peripheral artery occlusive disease who are scheduled to undergo femoropopliteal peripheral bypass surgery. The primary objective of the study is to evaluate graft safety and efficacy.
The investigational Fusion Vascular Grafts are synthetic vascular grafts constructed of two layers – an inner layer comprised of extruded, expanded polytetrafluoroethylene (ePTFE) and a PET knit polyester textile outer layer. These two layers are fused together with a proprietary polycarbonate-urethane adhesive. The investigational Fusion Bioline Vascular Graft is coated on the luminal service with recombinant albumin and heparin.