WAYNE, NJ--(Marketwire - May 19, 2011) - MAQUET Cardiovascular today announced that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market its CARDIOROOT aortic graft in the U.S. An innovative, one-piece design, aortic root graft, CARDIOROOT will be used by vascular and cardiovascular surgeons to surgically repair or replace diseased and damaged aortae. CARDIOROOT is now commercially available in the U.S.
The unique design of CARDIOROOT mimics the anatomy of the patient's native aortic root, including the clinically important natural sinuses of valsalva, which supply blood to the heart's own arteries. CARDIOROOT's anatomically correct shape allows easy sewing of valve remnants or a prosthetic valve within the tube, thereby avoiding potential bleeding while shortening surgical procedure time.
"The CARDIOROOT graft is an important option for aortic root repair. The graft wall is supple, allowing better approximation with tissue. The unique properties of the graft material provide ease of suturing and superb predictability of the final geometry," said Marc W. Gerdisch, M.D., chief of cardiothoracic surgery at Franciscan St. Francis Heart Center in Indianapolis, Ind., and a clinical assistant professor of cardiothoracic surgery at Loyola University Medical Center. A pioneer in exploring and applying the latest in medical technology, Dr. Gerdisch is the first cardiothoracic surgeon in the United States to use CARDIOROOT on a critically ill patient. "The improved hemostasis is an added advantage of CARDIOROOT for complex aortic root reconstructions, substantially contributing to a dry surgical field at the end of the surgery."
"CARDIOROOT's innovative design exemplifies our longstanding tradition of providing novel surgical grafts to cardiothoracic and vascular surgeons that benefit their patients," said Bodo Anders, President and Chief Executive Officer of MAQUET Cardiovascular Vascular Interventions. "This graft provides surgeons with an aortic root prosthesis that mimics the patients' anatomy and has the outstanding handling and suturability characteristics that are the hallmarks of MAQUET surgical grafts, which are used every day in life-saving procedures across the U.S."
"The availability of CARDIOROOT enhances our portfolio of products with another ground-breaking solution for our customers," said Raoul Quintero, President of MAQUET Cardiovascular U.S. Sales. "The launch of CARDIOROOT in the U.S. further exemplifies our commitment to providing surgeons the tools and resources necessary to ensure the Gold Standard in patient care."
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 CARDIOROOT aortic 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 and have 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, and the INTERGARD ULTRATHIN heparin-coated graft, designed to promote graft patency.
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.