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Landmark study results published in NEJM highlight breakthrough treatment for heart failure

MINNEAPOLIS, June 12, 2002 - Hundreds of thousands of Europeans who live with restricted energy, mobility and independence due to heart failure could benefit significantly from a breakthrough treatment featured in tomorrow's New England Journal of Medicine1. The published study results demonstrate the benefit of cardiac resynchronisation (CR) therapy with the InSync system from Medtronic, Inc. (NYSE: MDT) to help many people live well with moderate-to-severe heart failure. Over 3 million people in the G5 European markets alone (UK, Germany, Italy, France & Spain) suffer from heart failure2, a progressive and debilitating condition that is responsible for more hospitalisations than all forms of cancer combined.

Data from the Multicenter InSync Randomised Clinical Evaluation, known as MIRACLE, show that cardiac resynchronisation therapy systems helped many patients improve by at least one functional class, resulted in a greater improvement in patient quality of life than for those receiving drug therapy alone and reduced the risk of hospitalisation from worsening heart failure.

Approximately 450,0003 people in the G5 European countries are candidates for cardiac resynchronisation therapy; these patients have moderate-to-severe heart failure and also suffer from ventricular dysynchrony, which occurs when there is a time delay between the beating of the heart's two lower chambers, or ventricles. Cardiac resynchronisation therapy delivers electrical impulses to both sides of the heart to co-ordinate the contractions of the heart's ventricles and improve its efficiency to increase blood flow to the body.

The MIRACLE study was designed to measure therapeutic benefits of the InSync system, as determined by changes in New York Heart Association (NYHA) functional classification, distance walked in six minutes and improvements in quality of life. Findings are based on data from 453 patients with moderate-to-severe heart failure.

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Contact: Amanda Boswell
amanda.boswell@ketchum.com
44-207-611-3571
Ketchum
12-Jun-2002


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