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MAQUET Cardiovascular Initiates Study Evaluating Use of Minimally Invasive Endoscopic Vessel Harvesting Technique as Standard of Care in Coronary Artery Bypass Surgery

Monday, January 25, 2010 General News J E 4
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- OPTION Trial Designed to Address Conduit Quality of Endoscopically-Harvested Grafts Using Optimal Technologies and Procedure Protocols -

WAYNE, N.J., Jan. 25 /PRNewswire/ -- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced the initiation of the OPTION (Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques) study. This clinical trial is designed to evaluate the equivalence of Endoscopic Vessel Harvesting (EVH) in Coronary Artery Bypass Graft (CABG) surgery compared with historical data for open vein harvesting.  David Moore, M.D., of THE HEART HOSPITAL Baylor Plano is the principal investigator for the OPTION trial.

"We believe the OPTION study will address the shortcomings of previous studies evaluating EVH in CABG.  The study will emphasize the importance of standardization in harvest procedure, operator experience and medical management, and provide a more contemporary representation of the quality of conduit harvested with the EVH technique," said Michael J. Mack, M.D., Research Director, THE HEART HOSPITAL Baylor Plano.  

OPTION is a 100-patient, single-center study that will evaluate vein graft patency at one month and one year following CABG surgery.  The study standardizes a number of pre- and post-harvesting factors and will utilize the VASOVIEW HEMOPRO technology system, as well as experienced harvesters with the appropriate skill level to best preserve and protect the vessel.  

"The OPTION study underscores MAQUET Cardiovascular's commitment to advancing EVH instrumentation and procedures as well as advancing the dialogue among cardiovascular surgeons about the benefits of EVH," said Luca Lombardi, M.D., Chief Medical Officer of MAQUET Cardiovascular.  "We believe the OPTION study's scientific rigor will validate the safety and efficacy of EVH, without subjecting patients to complications associated with open harvesting techniques that a randomized study would require."

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 Endoscopic Vessel Harvesting (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.

www.maquet.com

www.getingegroup.com

MAQUET – The Gold Standard.

SOURCE MAQUET Cardiovascular LLC

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