Maquet Fusion Bioline Vascular Graft Receives CE Mark Approval

March 16, 2011—Maquet Cardiovascular (Wayne, NJ) announced that it has received European CE Mark approval for its Fusion Bioline vascular graft.
 The Fusion Bioline is indicated for surgical bypass treatment of patients with peripheral artery disease. 

The Fusion Bioline builds on the company's Fusion synthetic graft that is constructed of two layers that are fused together. An inner layer is composed of extruded, expanded polytetrafluoroethylene (ePTFE) and an outer layer composed of a knit polyester textile. The Fusion Bioline adds to this platform with the heparin-based Bioline coating on the inside of the ePTFE layer of the graft. Maquet's Bioline coating combines a layer of albumin with heparin. The Bioline coating has demonstrated a reduction in clotting activity and a reduction of platelet adhesion and thrombi creation on Maquet's cardiopulmonary products, the company stated.
 


“The new Fusion Bionline vascular graft combines the benefits of polyester and ePTFE grafts, which include no suture hole bleeding and improved graft patency due to the inner heparin coating,” commented Afshin Assadian, MD. “The combination of these two graft materials, together with the benefit of offering a product with heparin coating, takes vascular grafts to the next level. I expect it will result in improved long-term graft patency and optimal patient satisfaction.”