WAYNE, NJ--(Marketwire - March 16, 2011) - MAQUET Cardiovascular today announced that it has received European CE Mark approval for its FUSION BIOLINE Vascular Graft, which is indicated for use in patients with peripheral artery disease (PAD).
Unlike traditional vascular grafts that utilize a single material, the FUSION Vascular Graft is a synthetic graft constructed of two layers -- an inner layer comprised of extruded, expanded polytetrafluoroethylene (ePTFE) and an outer layer comprised of a PET knit polyester textile. These two layers are fused together with a proprietary polycarbonate-urethane adhesive. This unique two-layer construction delivers patient benefits both during and after surgery, including axial compliance for better handling compared with standard ePTFE grafts; high suture retention strength and durability for long-term performance; and minimal suture hole bleeding for improved hemostasis. FUSION BIOLINE builds upon this platform with the addition of a heparin-based BIOLINE coating on the inside of the ePTFE layer of the graft. BIOLINE coating, which has been used successfully on MAQUET’s cardiopulmonary product line since 1995, combines a layer of albumin, the main blood protein, with heparin, a substance widely known as a safe and effective anti-thrombogenic. This coating is designed to offer the anticoagulant properties of heparin on a peripheral bypass graft. BIOLINE coating on MAQUET’s cardiopulmonary products has demonstrated a reduction in clotting activity(i) and a reduction of platelet adhesion and thrombi creation.(ii)(iii)
“The new FUSION BIOLINE 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,” said Afshin Assadian, M.D., Head of the Department of General and Vascular Surgery at Wilhelminenspital Vienna in Austria. “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.”
An estimated 6 million adults in Europe are affected by PAD, a condition of the blood vessels that leads to narrowing and hardening of the arteries that supply the legs and feet and may threaten the function and integrity of a limb. Patients with severe PAD may require peripheral artery bypass surgery of the leg, in which a vein from another part of the body or a synthetic graft is used to bypass blockages and restore blood flow.
“By adding the benefits of heparin to the unique FUSION hybrid construction, the FUSION BIOLINE graft sets a new standard for peripheral bypass grafting,” said Bodo Anders, President of MAQUET Cardiovascular’s Vascular Interventions Business Unit. “We look forward to commercializing this innovative graft in Europe, which continues our longstanding tradition of providing advancements in surgical grafts to cardiothoracic and vascular surgeons to benefit their patients.”
MAQUET’s Portfolio of Vascular Grafts All MAQUET vascular grafts are designed for optimal patient outcomes and feature technologies to improve hemostasis, encourage tissue in-growth, promote natural healing and provide long-term durability.
The FUSION BIOLINE graft is the latest addition to MAQUET Cardiovascular’s portfolio of market-leading surgical grafts, which includes the HEMASHIELD line of aortic grafts, the most used and most studied vascular grafts in the world cardiothoracic surgical market. More than 2 million HEMASHIELD grafts have been implanted in patients worldwide, with clearly demonstrated clinical efficacy and improved outcomes. MAQUET’s INTERGARD grafts include the innovative INTERGARD Knitted grafts with reverse Locknit construction to resist postoperative dilatation, the INTERGARD ULTRATHIN heparin-coated graft, designed to promote graft patency, and INTERGARD SILVER, the world’s first antimicrobial surgical graft.
About MAQUET As a trusted partner for hospitals and clinicians since 1838, MAQUET is a global leader in medical systems that advance surgical interventions, cardiovascular procedures and critical care. MAQUET develops and designs innovative products and therapeutic applications for the operating room, hybrid OR/cath lab, intensive care unit and patient transport within acute care hospitals, improving outcomes and quality of life for patients.
Cardiovascular specialties include intra-aortic balloon counterpulsation (IABC) therapy for cardiac assist; coronary artery bypass surgery; aortic and peripheral vascular surgery; and extracorporeal circulation. The Critical Care portfolio includes market-leading intensive care ventilators and anesthesia machines. MAQUET also equips Surgical Workplaces with critical infrastructure, such as flexible room design for OR and ICU; OR tables; lights and ceiling supply units; and OR integration for image data management.
MAQUET is a subsidiary of the publicly listed Swedish GETINGE GROUP. In 2010, MAQUET generated nearly half of the company’s annual revenue of $3.2 billion. The company has 12,000 employees worldwide, including 5,000 employees in 36 international sales and service organizations, as well as a network of more than 250 sales representatives. For more information please visit www.maquet.com and www.getingegroup.com.
MAQUET -- The Gold Standard.
(i) Fraedrich et al. A new covalent heparin bonding process of extracorporeal circuits improves the hemocompatibility of cardiopulmonary bypass equipment. Clinical study presented at the 23rd Congress of the German Society for Thoracic and Cardiovascular Surgery, Germany,1995.
(ii) Feyrer et al. Reduction of neuropsychological dysfunction after cardiac surgery with heparin-coated cardiopulmonary bypass circuits. Kardiotechnik. January 1998.
(iii) Palatianos et al. A prospective, double-blind study on the efficacy of the BIOLINE surface heparinized extracorporeal perfusion circuit. Ann Thoracic Surg. 2003;129-35.
