MAQUET Cardiovascular Announces Enrollment of First Patient in Study Evaluating Best-Practice Endoscopic Vein Harvesting in Coronary Artery Bypass Surgery

WAYNE, N.J., Sept. 22 /PRNewswire/ -- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced enrollment of the first patient in the OPTION (Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques) trial which is designed to assess patient outcomes using a standardized, best practices approach in endoscopic vessel harvesting (EVH) for coronary artery bypass graft surgery (CABG) compared with open vein harvesting methods.

The 100-patient OPTION trial is being led by principal investigator, Dr. David Moore of the HEART HOSPITAL Baylor Plano and will be conducted at that center as well as the Medical City Dallas Hospital, which enrolled the first patient (a 65-year-old male, who received four grafts with two arteries and two grafts using saphenous veins harvested using MAQUET's VASOVIEW HEMOPRO 2 EVH system).

"The OPTION study is an important and timely trial because the protocol standardizes harvest procedure, operator experience and medical management. As a result, it will address the shortcomings of previous studies and provide a more contemporary representation of the quality of conduit harvested with the EVH technique," said Dr. Moore.  

"As recently observed with the three-year SYNTAX data, surgery is the best option for close to two-thirds of patients with coronary artery disease," said Dr. Subramanian, M.D., Chairman, Department of Cardiothoracic Surgery, and Director, Department of Surgery at Lenox Hill Hospital in New York. "As more patients are indicated for surgery, it is important to ensure the highest level of conduit vessel quality through the use of next generation technology to further improve the surgeon's experience and patient outcomes."  

The OPTION study will utilize the latest generation VASOVIEW HEMOPRO 2 EVH System, allowing harvesters to achieve zero thermal spread which will further protect conduit quality and improve clinical outcomes and patient quality of life.

Additionally, the study is utilizing experienced harvesters with an appropriate skill level to best preserve and protect the vessel. The study also standardizes a number of pre- and post-harvesting factors, including the use of controlled pressure during conduit preparation with MAQUET's VASOSHIELD Pressure Controlling Syringe.  Vein graft patency will be evaluated at one month and one year following CABG surgery.

"Enrollment of the first patient in the OPTION trial represents an important milestone, as we believe the study will significantly advance EVH practice by validating state-of-the-art EVH instrumentation and best harvest techniques as well as reinforce the benefits of EVH among the cardiovascular community," said Luca Lombardi, M.D., Chief Medical Officer of MAQUET Cardiovascular.  

About EVH

In EVH, a healthy blood vessel, such as the saphenous vein from the leg or the radial artery from the arm, is removed through a small incision for use during CABG surgery to bypass a blockage in the heart.  Open vein harvesting requires a lengthy incision that is often extremely painful and prone to healing complications.  EVH offers several patient benefits, including faster healing, less postoperative pain and scarring, and reduced risk of wound complications, such as infection. These well-established benefits have resulted in EVH becoming the standard of care in the United States, with 80 percent of all CABG surgeries utilizing this technique.

MAQUET is a global supplier of the market-leading VASOVIEW EVH System.

About MAQUET Cardiovascular

MAQUET Cardiovascular 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 was formed in 2003 when MAQUET, the world's leading medical technology company, combined its existing Cardiopulmonary business with Jostra's equipment and consumables for open heart surgery and Siemens Life Support Systems, which the publicly-listed Swedish GETINGE Group acquired in 2003. In 2008, MAQUET added the Cardiac Surgery and Vascular Interventions businesses acquired by GETINGE from Boston Scientific and Guidant. In 2009, it added the cardiac assist businesses that GETINGE acquired from Datascope. 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) and Intensive Care Unit (ICU). The integrated products of MAQUET are specially designed to deliver optimal clinical treatment and therapy concepts 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, aneurysm and vascular repair, peripheral interventions and extracorporeal circulation
• Critical Care -- for intensive care ventilators and anesthesia machines
• Surgical Workplaces -- for OR tables, lights and ceiling service units, prefabricated OR and ICU suites as well as telemedicine for the OR integration.

MAQUET is a subsidiary of the publicly-listed Swedish GETINGE GROUP, a company with over $2.8 billion in revenues (2008 fiscal year) and 12,800 employees worldwide. In 2008 MAQUET itself generated pro-forma revenues (including the acquisition of Datascope Corp.) of over $1.4 billion. The company now has 5,000 employees in 35 international sales and service organizations, as well as a network of more than 200 sales representatives.

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SOURCE MAQUET Cardiovascular LLC