MAQUET Cardiovascular Announces First Patient Enrolled in Randomized Investigational Device Exemption Clinical Trial of FUSION and FUSION BIOLINE Vascular Grafts

WAYNE, N.J., May 25 /PRNewswire/ -- 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.

About MAQUET Cardiovascular

MAQUET Cardiovascular was formed in 2003 and is a leader in providing innovative products for cardiac surgery, vascular intervention and cardiac support to hospitals and clinics and the cardiac surgeons, interventional cardiologists, perfusionists and other healthcare professionals who care for patients with cardiovascular disease. MAQUET Cardiovascular is focused on providing clinicians with future-oriented technology that fits into their daily practice and improves the therapeutic management of patients. MAQUET Cardiovascular continues to invest in the development of innovative technologies and solutions that advance clinical practice, improve patient outcomes and enhance quality of life.

MAQUET Cardiovascular provides healthcare professionals with products in four business units: Cardiopulmonary (perfusion products), Cardiac Surgery (clampless beating heart and endoscopic vessel harvesting), Vascular Interventions (grafts for vascular surgery), and Cardiac Assist (intra-aortic balloon counterpulsation therapy).

About The MAQUET Group

The MAQUET Group is the global market leader for Medical Systems, focusing on the Operating Room (OR), Cath Lab, Intensive Care Unit (ICU) and Patient Transport. The integrated products of MAQUET are specially designed to deliver optimal clinical treatment and therapeutic applications within acute care hospitals. MAQUET provides innovative medical solutions from three Divisions:

• Cardiovascular with products for cardiac assist (intra-aortic balloon counterpulsation therapy), coronary artery bypass surgery, complex aortic surgery reconstruction, peripheral interventions and extracorporeal circulation.
• Critical Care for intensive care ventilators and anesthesia machines
• Surgical Workplaces for OR tables, lights and ceiling service units, flexible room design for OR, Cath Lab and ICU as well as digital OR integration.

MAQUET is a subsidiary of the publicly-listed Swedish GETINGE GROUP, a company with around $3 billion in revenues (2009 fiscal year) and 12,100 employees worldwide. In 2009 MAQUET itself generated revenues of around $1.5 billion. The company now has more than 5,000 employees in 36 international sales and service organizations, as well as a network of more than 250 sales representatives. Twelve manufacturing sites are located in 6 countries.

www.maquet.com

www.getingegroup.com

MAQUET – The Gold Standard.

SOURCE MAQUET Cardiovascular LLC