First implant and start of global clinical trials for Advantage, Medtronic's new prosthetic heart valve

Minneapolis 03 December 1999Medtronic Inc. has announced the first implant and the start of worldwide human clinical trials for its Advantage bileaflet mechanical heart valve. Approximately 265.000 prosthetic valves are implanted globally each year, and it is estimated that mechanical valves are used in about 60 percent of these cases. Prosthetic heart valves are utilised by surgeons to replace the heart's natural valves whenever they have been rendered ineffective by age or are damaged by disease, making it difficult for blood to be pumped efficiently through the heart.

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Patients and physicians most often choose mechanical valves, for they are in search of long-term durability. The overall market for mechanical heart valves is estimated at $400 million annually. Professor Reiner Korfer of the Herzzentrum NordRhein-Westfalen in Bad Oeynhausen, Germany, has successfully performed the first implant of the Advantage heart valve on 25th of November, 1999. The recipient was a 49 year-old male patient with aortic valve disease. Bad Oeynhausen is Europe's largest dedicated cardiac surgery centre, performing over 4200 open heart cases each year.

This implant is the first in a multi-centre, worldwide clinical study which will evaluate the performance and safety of the Medtronic Advantage heart valve, involving leading cardiac surgery centres from Europe, Canada, Australia, and the United States. "The start of the global clinical evaluation for the Advantage heart valve represents the latest step in the commitment of Medtronic to serve the varied needs of physicians and patients all over the world", stated Jim Foster, who is Vice President and General Manager of Medtronic's Heart Valve Division.

The Medtronic Advantage heart valve has been designed to combine the best attributes from other currently available mechanical heart valves. The design has been tested, utilising state-of-the-art microflow analyses, including the use of supercomputers. The Medtronic Advantage heart valve integrates the patented pyrolytic carbon technologies, called Surface Engineering. It is also developed to provide ease of implant for both conventional and less-invasive placement techniques.

The Advantage bileaflet mechanical heart valve is developed to complement the company's complete product line of cutting-edge tissue and mechanical valves, including heart valves, such as the Freestyle, the Mosaic that is only available outside the United States, the Hancock II, and the Medtronic Hall. Medtronic Inc., headquartered in Minneapolis, is the world's leading medical technology company, specialised in implantable and interventional therapies which restore health, extend life and alleviate pain.


Leslie Versweyveld

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