CARE-HF Clinical Trial Completes Full Enrollment, Will Examine the Effects of Cardiac Resynchronization Therapy on Mortality and Morbidity of Heart Failure Patients.

Business Editors/Health/Medical Writers

MINNEAPOLIS--(BUSINESS WIRE)--March 31, 2003

Medtronic-sponsored study follows tradition of MUSTIC, MIRACLE

and MIRACLE ICD trials

Medtronic, Inc. (NYSE:MDT), today announced that full enrollment has been reached for the large CARE-HF (Cardiac Resynchronization in Heart Failure) clinical trial in Europe, a key study of mortality and morbidity among moderate to severe heart failure patients who receive cardiac resynchronization therapy.

The CARE-HF trial enrolled more than 800 patients at 82 clinical centers in 12 European countries. It has the largest control group of any heart failure trial to date (404 patients receiving optimal medical therapy from drugs) and is the most statistically robust heart failure trial due to the size of its control group and the length of follow-up. It is designed to evaluate the long-term outcome of cardiac resynchronization therapy on the mortality (survival) and morbidity (chronic sickness) of patients with heart failure due to left ventricular dysynchrony. The primary end-point is all-cause mortality (death from any cause) or unplanned cardiovascular hospitalizations. Patients are followed for a period of 18 months.

Other major clinical trials sponsored by Medtronic such as MUSTIC, MIRACLE and MIRACLE ICD have shown dramatic benefits for many heart failure patients who receive cardiac resynchronization therapy, including improved exercise capacity, quality of life and clinical symptoms. Some patients have even been removed from heart transplant waiting lists due to their improvement with cardiac resynchronization therapy. However, the long-term mortality and morbidity benefits have yet to be established.

"The data from this key study will go a long way toward crystallizing the mortality effects of cardiac resynchronization therapy on serious cardiovascular events," said Professor J.G.F. Cleland, chairman of the CARE-HF steering committee and head of the Department of Cardiology, Castle Hill Hospital, Kingston-upon-Hill, United Kingdom. "CARE-HF will provide more information on the effects of CRT on morbidity and mortality than all of the published evidence put together, and more data than any other outcome study initiated so far."

CARE-HF differs from other CRT mortality studies in that it is the only heart failure trial powered to assess the impact of cardiac resynchronization therapy alone on mortality and morbidity. In addition, it was prospectively designed to assess the endpoints from the time of enrollment, a true measure of the "intent-to-treat" nature of the study.

"Medtronic has a long legacy of leadership in ground-breaking heart failure trials," said Ursula Gebhardt, vice president and general manager of Medtronic's global heart failure business. "The stage was set with MUSTIC, and subsequent trials such as MIRACLE, MIRACLE ICD, CARE-HF and SCD-HeFT are helping to provide the medical community with critical information about outcomes and treatment options for heart failure patients. CARE-HF will reinforce what we've learned from previous trials and take it a step further."

In the past two years, implantable device therapy has opened a new era of novel heart failure treatment that complements drug therapy. Cardiac resynchronization therapy has become an increasingly important therapeutic option for physicians treating patients with moderate to severe heart failure who are already receiving optimal drug treatment such as ACE inhibitors and beta-blockers. To date, more than 40,000 Medtronic CRT systems have been implanted worldwide.

Recently, the Journal of the American Medical Association (JAMA) published a statistical analysis of four important heart failure studies. That analysis, based on pooled data from 1,634 patients in these prior studies, showed that cardiac resynchronization therapy reduced death from progressive heart failure by 51 percent compared with patients who only received drug therapy.

Heart failure affects more than 22 million people worldwide, including 6 million in Europe and 5 million in the United States, with approximately 500,000 new patients diagnosed each year. It is the only cardiac condition that is increasing in prevalence and is a major cost and quality of life issue, characterized by frequent hospitalizations.

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 the company's Annual Report and on Form 10-K for the year ended April 26, 2002. Actual results may differ materially from anticipated results.