Medtronic Releases New ADVANTAGE Supra Bileaflet Mechanical Heart Valve to Surgeons in Europe, Canada.
MINNEAPOLIS--(BUSINESS WIRE)--Nov. 25, 2003
Designed for Ease of Implant and Maximum Blood Flow
in Supra-Annular Aortic Position
Medtronic, Inc. (NYSE:MDT), today announced market introduction in Europe and Canada of the Medtronic ADVANTAGE(R) Supra(TM) bileaflet mechanical aortic heart valve. Its supra-annular design allows a larger valve to be implanted, thereby optimizing blood flow, which is the key to reducing the workload on the heart and improving patient outcomes.
CE (Conformite Europeenne) Mark approval in countries of the European Union and approval by the Canadian Therapeutic Products Directorate places the ADVANTAGE supra-annular model in a growing segment of the world market for mechanical aortic valves that replace diseased or damaged natural aortic heart valves. Opening and closing about 100,000 times daily to form the gateway from the heart to the rest of the body, such prosthetic valves are used in an estimated 50,000 procedures annually in Europe and about 6,500 each year in Canada.
The ADVANTAGE Supra valve joins Medtronic's standard ADVANTAGE mechanical valve in offering SureFlow(TM) Technology, a proprietary design engineered to facilitate implantation and optimize blood flow across the valve and through its pivot region. The new Supra model features a polyester sewing cuff shaped to allow the valve to be sutured in place completely above the natural aortic valve position. This allows the valve's two leaflets to open and close outside and above the confines of a small aortic root or in other anatomical situations where flow would be compromised by standard valve placement.
"For those who prefer to implant a valve in the supra-annular position, this is the perfect valve," said Prof. Dr. med. Reiner Korfer, principal investigator at the Heart and Diabetes Center in Bad Oeynhausen, Germany, one of the world's leading heart centers. "The Medtronic ADVANTAGE Supra is an important addition to the heart surgeon's options. It gives us a technologically advanced alternative for special situations, along with features proved by the standard ADVANTAGE model. The enlarged central flow area and supra-annular positioning are intended to optimize blood flow through and across the valve, while its innovative pivot mechanism allows blood to gently wash the pivot recess throughout the cardiac cycle."
Designed to function smoothly, precisely and safely for years deep within the human heart, the ADVANTAGE valves are engineered to combine and enhance the best attributes from other currently available mechanical heart valves. They are currently in clinical evaluation in the United States, Japan and Australia.
The large central flow opening featured by Medtronic ADVANTAGE valves is designed to reduce velocity and blood turbulence. Other features emphasize the traditional durability of mechanical valves and provide ease of implant in conventional techniques. Each valve itself consists of a cylindrical pyrolytic carbon housing with two pyrolytic carbon leaflets that open to 86 degrees and then close within the valve housing, which is surrounded by the fabric sewing ring. Sure-Flow(TM) "butterfly" pivot recesses, which retain the leaflets firmly in the housing, improve the process of washing the sensitive pivot regions. Blood flow through the valve is further aided by a patented pyrolytic carbon technology -- Surface Engineering -- which results in smooth transitional surfaces for unobstructed, gentle flow.
The Medtronic ADVANTAGE bileaflet heart valves complement Medtronic's complete product line of valve repair products, and tissue and mechanical valves, including the Duran Flexible and CG Future(TM) Band annuloplasty systems; Freestyle(R), Mosaic(R) and Hancock(R) II tissue valves; and the Medtronic Hall(R) mechanical heart valve. For additional information on the Medtronic heart valve replacement/repair product portfolio, please access www.heartvalves.com.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.
Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.
NOTE TO EDITORS: In Prof. Dr. med. Reiner Korfer's name noted in this news release, there is an umlaut above the "o" in Korfer. This symbol may not appear properly in some systems.
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|Date:||Nov 25, 2003|
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