MAQUET Cardiovascular commences enrollment in trial of FUSION and FUSION BIOLINE Vascular Grafts

MAQUET Cardiovascular LLC today announced enrollment of the first patient in FINEST (FUSION Vascular Graft, FUSION Vascular Graft with BIOLINE and EXXCEL SOFT ePTFE). This prospective, randomized, single-blind, three-arm, parallel group, multi-center 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, MD at VA Palo Alto Health Care System in Palo Alto, CA.  

"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, M.D., a vascular surgeon at Methodist Hospital in Houston. "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 enroll 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 femoral popliteal peripheral bypass surgery. The primary objective of the study is to evaluate graft safety and efficacy.  

Peripheral artery disease is a condition of the blood vessels that leads to narrowing and hardening of the arteries that supply the legs and feet. Treatment options include regular exercise, improved diet and medication prescribed by a physician. For some patients, these treatments are not enough and minimally invasive treatment or surgery may be needed. Surgical options include peripheral artery bypass surgery of the leg or angioplasty and stent placement in the peripheral arteries of the affected extremity.

"We are pleased to begin this trial of our FUSION peripheral grafts as we believe they represent an innovative advancement in vascular grafts. We believe that the addition of the BIOLINE coating to the unique FUSION hybrid construction will set a new standard for peripheral bypass treatment," said Bodo Anders, President of MAQUET Cardiovascular's Vascular Interventions Business Unit.

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.