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Younger Patients Get New Options as Heart Specialists Revise Guidelines for Valve Procedures


ACC and AHA Joint Committee Revised Guidelines Recognizing Porcine Tissue Valves as More Durable, Offer Possibility of Long-term Use Without Anticoagulation Medication

MINNEAPOLIS – June 23, 2006 – Baby boomers needing a prosthetic replacement for a diseased or damaged heart valve receive significant new life-enhancing options in revised guidelines for the treatment of cardiac valvular disease. The revised guidelines were issued recently by a joint committee of the American College of Cardiology and the American Heart Association.

The heart’s four valves open and close more than 100,000 times a day to facilitate and control the flow of blood from the main pumping chamber of the heart into the circulatory system which carries it throughout the body. According to the American Heart Association, more than 100,000 Americans undergo valve replacement or repair procedures each year.

Robert Hubert, vice president and general manager of the Heart Valves business at Medtronic, Inc. (NYSE: MDT), credited technological process improvements resulting in increased durability for the committee’s endorsement of wider use for prosthetic valves crafted from animal tissues. “We anticipate further advances in this area with Medtronic’s third-generation offerings and we are proud that the record of Medtronic’s second-generation tissue valves has enabled them to meet the exacting durability standards of the committee,” he said. “The recognition of durable replacement bioprostheses that may not require years of anticoagulation medication is indeed a welcome milestone for the industry and for doctors and patients considering which new valve to choose.”

The revised guidelines are intended to update guidance for internists, cardiologists and surgeons as they diagnose disease, counsel patients and plan valve replacement procedures. Two significant revisions hold key implications for patient care:

* Responding to the increasing durability of valves crafted from animal tissues, the task force supported tissue valve use for patients needing replacement of their mitral valves even if the patients are younger than 70. In the past, surgeons serving these patients typically selected mechanical metal valves because they were more likely to serve a younger patient for his or her increased lifespan. The tradeoff, however, is the requirement that mechanical valves necessitate ongoing daily anticoagulant medication. The revised guidelines, in effect, encourage surgeons to offer tissue valves, which may not require years of anticoagulation, to appropriate younger patients who have active lifestyle considerations.
* The committee recognized that technological improvements have made today’s second-generation porcine tissue valves for the aortic and mitral positions equivalent in durability to pericardial tissue valves made from bovine tissues. This equivalency further enlarges the range of options as surgeons discuss replacement with patients.

Medtronic, which did not participate in preparation of the revised guidelines, holds exclusive distribution rights for a pocket-size reference version during the next six months. Nationwide distribution of the guidelines began this week and they are scheduled to be published in the August issues of the Journal of the American College of Cardiology and Circulation, published by the American Heart Association. Full versions are posted at and

In addition to the second-generation porcine valves addressed in the latest guidelines, Medtronic has developed unique third-generation valve technologies including AOA®1 tissue treatment and the Physiologic Fixation™ process 2. Studies have shown that the Physiologic Fixation process preserves valve leaflet structure and provides leaflet function similar to natural aortic valves. AOA tissue treatment has been shown in laboratory studies to significantly reduce calcification and to sustain this effect for a longer duration than untreated tissue. Medtronic offers both of these technologies in its third-generation stentless Medtronic Freestyle® and stented Medtronic Mosaic® porcine tissue valves. The maximized orifice of the stentless Medtronic Freestyle bioprosthesis increases blood flow providing optimal hemodynamics. Mosaic ULTRA®, Medtronic’s newest tissue valve offering, combines third-generation technologies with enhanced design to further improve hemodynamic performance.

About Medtronic
Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.


Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-Q for the year ended January 27, 2006. Actual results may differ materially from anticipated results.


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