May 20, 2004
Results of Guidant's Landmark Heart Failure Trial Published in New England Journal of Medicine

Trial Results Support Therapy for Extending and Improving the Lives of People with Advanced Heart Failure

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE: GDT) today announced that results of the landmark Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial were published in the issue of the New England Journal of Medicine. Trial results achieved the primary endpoint of a risk reduction for events consisting of either time to death or first hospitalization, for any cause, following implant of cardiac resynchronization therapy pacemakers or defibrillators. Additionally, treatment with resynchronization therapy defibrillators demonstrated a significant reduction in all-cause mortality. All patients also received optimal heart failure drug therapy.

"COMPANION proves for the first time that significantly improved patient outcomes can be achieved with cardiac resynchronization therapy, over and above optimal drug therapy," said Michael R. Bristow, M.D., Ph.D., University of Colorado Health Sciences Center and COMPANION study co-chairman. "Heart failure is a major public health problem. Despite improvements in drug therapy, heart failure continues to have serious consequences, including high rates of hospitalization, death and poor patient quality of life."

Heart failure is a debilitating condition that affects a patient''s quality of life and life expectancy. It is a condition in which the heart weakens and gradually loses the ability to pump blood effectively.

• Nearly 5 million Americans are currently living with heart failure, and more than 250,000 of these people die each year
• More than 6 million Europeans are currently affected
• Nearly 1 million new cases of heart failure are diagnosed annually worldwide, making it the most rapidly growing cardiovascular disorder.

The COMPANION trial included 1,520 heart failure patients from 128 clinical trial sites across the United States. All patients had advanced heart failure, a wide QRS and depressed pumping function of the left ventricle. QRS is a measurement of how long it takes to get the ventricles electrically activated. While previous clinical studies demonstrated cardiac resynchronization therapy devices improve exercise performance and quality of life only, the COMPANION trial yielded the following results, each as compared to optimal drug therapy alone:

• A 19 percent risk reduction in combined all-cause mortality or first all-cause hospitalization for heart failure patients assigned to receive Guidant''s cardiac resynchronization therapy pacemakers
• A 20 percent risk reduction in combined all-cause mortality or first all-cause hospitalization for heart failure patients assigned to receive Guidant''s cardiac resynchronization therapy defibrillators
• A 36 percent risk reduction in all-cause mortality for heart failure patients assigned to receive Guidant''s cardiac resynchronization therapy defibrillators
• Both cardiac resynchronization therapy and cardiac resynchronization therapy with defibrillation reduced symptoms and improved quality of life

These results have been submitted to the U.S. Food and Drug Administration for review to potentially expand indications and user labeling for Guidant cardiac resynchronization therapy devices.

"The publication of COMPANION data in a prestigious medical publication such as the New England Journal of Medicine provides clear validation of the importance of this study," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "Guidant is committed to innovation in heart failure therapies. We continue to invest aggressively in research and development to identify new ways to improve treatment for people who suffer from cardiac and vascular diseases."

What is Cardiac Resynchronization Therapy?

Both cardiac resynchronization therapy pacemakers and cardiac resynchronization therapy defibrillators improve the heart''s pumping ability by delivering small electrical impulses that help synchronize contractions of the left ventricle. The left ventricle is the heart''s main pumping chamber, and its ability to pump blood is enhanced when the muscular walls contract synchronously. In addition, cardiac resynchronization therapy defibrillators monitor the heart for potentially fatal rhythms. If such a rhythm is detected, a lifesaving shock is delivered, restoring normal heart rhythm and preventing sudden cardiac death.

About the COMPANION Trial:

The COMPANION trial, sponsored solely by Guidant, was a prospective, multi-center, randomized study of patients with advanced heart failure. The patients studied in this trial had diminished function of the left ventricle (an ejection fraction at or below 35 percent), a wide QRS complex (≥120 milliseconds) and advanced heart failure. The trial included 1,520 patients at 128 centers in the United States. All patients received optimal heart failure drug therapy. The COMPANION trial used Guidant''s CONTAK TR® cardiac resynchronization therapy pacemaker in one patient group and the CONTAK CD® cardiac resynchronization therapy defibrillator in another patient group. The third patient group received optimal drug therapy only.

About Guidant''s clinical leadership:

The COMPANION trial follows in the tradition of two previous landmark trials, MADIT (Multicenter Automatic Defibrillator Implantation Trial) and MADIT II, each exclusively sponsored by Guidant. The results of these trials led to breakthroughs in the prevention of sudden cardiac death. A third trial, MADIT-CRT, will begin enrolling patients later this year.

• MADIT: Proved for the first time that prophylactic implantable cardioverter defibrillator therapy can dramatically improve survival in high-risk patients.
• MADIT II: Proved heart attack survivors with impaired heart function (an ejection fraction at or below 30 percent) benefit from implantable cardioverter defibrillator therapy. Ejection fraction is the measurement of how efficiently the heart is pumping (or ejecting) blood to the body.
• MADIT-CRT: Designed to test whether cardiac resynchronization therapy defibrillators will slow the progression of heart failure in patients with impaired heart function and little or no symptoms. The trial will determine if earlier intervention with cardiac resynchronization therapy defibrillators can slow a patient''s progression from early stage heart failure to late stage heart failure.

About Guidant

Guidant Corporation is a world leader in the treatment of cardiac and vascular disease. The company pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. Driven by a strong entrepreneurial culture of 12,000 employees, Guidant develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life''s most threatening medical conditions. For more information visit www.guidant.com.