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Mosaic® Bioprosthetic Heart Valve Backgrounder
THE MEDTRONIC MOSAIC® HEART VALVE:
A NEW CHAPTER IN TISSUE VALVE REPLACEMENT
What It Is
The Medtronic Mosaic® bioprosthetic heart valve (bioprosthesis), carefully crafted from porcine tissue and preserved with innovative techniques, is an artificial heart valve.
What It Is Used For
A cardiothoracic surgeon may implant an artificial heart valve to replace a diseased or damaged natural heart valve, usually the aortic valve. Opening and closing more than 100,000 times a day, the heart’s four valves facilitate and control the flow of blood from the main pumping chamber of the heart into the circulatory system, which takes it to the rest of the body.
How to Describe the Mosaic Valve
The Medtronic Mosaic bioprosthesis is a third-generation valve made of porcine (pig) tissue. The tissue is attached to a cloth-covered, flexible plastic frame, called a stent. The bioprosthesis is then sewn into place where the patient’s diseased valve used to be.
What’s Different About the Mosaic Valve
The Mosaic porcine bioprosthesis includes technological advancements backed by 30 years of clinical research and experience in developing bioprosthetic replacement valves.
The primary goal of tissue scientists, valve engineers and surgeons, is to develop tissue valves that work as well and last as long as healthy, natural valves. In developing subsequent generations of tissue valves, these groups have worked together to mitigate two primary problems that can affect tissue valves: calcification and structural degeneration.
Recognizing the need to incorporate technologies that can potentially address these challenges, the Mosaic valve differs from previously-released tissue valves, in that it incorporates two proprietary technologies - the Medtronic AOA® 1,2 (alpha amino oleic acid) treatment and the Medtronic Physiologic Fixation™ process – which have not been available together in previous stented tissue valves. Both of these technologies have been shown in animal studies to maintain the natural leaflet structure of the valve and to reduce the potential for calcification of the animal tissue.
The Mosaic valve incorporates the proven stent of the Hancock®II valve - which is already recognized as one of the most durable in the world – and adds the advanced technologies of AOA tissue treatment and the Physiologic Fixation process. A major Hancock II study (published in the Journal of Thoracic and Cardiovascular Surgery, February 2001) showed only one failure due to valve stenosis or insufficiency after 15 years, in patients age 65 and over.
The Company Behind It
Medtronic, Inc., headquartered in Minneapolis, Minn., is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Its Cardiac Surgery business offers the broadest selection of heart valve products in the industry – including both mechanical and tissue valves, plus annuloplasty rings for surgical repair of the heart valve. Its Internet address is www.medtronic.com.
Medtronic tissue heart valves for both the aortic and mitral positions have undergone 30 years of development, and three distinct generations of bioprostheses have emerged. The third generation Mosaic bioprosthesis is the result of Medtronic’s commitment to advancing tissue technologies.
1 AOA is a registered trademark of Biomedical Design, Atlanta, GA.
2 No clinical data are available which evaluate the long-term impact of the AOA treatment in patients.