Nov 9, 2003
Guidant Announces Exclusive Sponsorship of MADIT-CRT Clinical Trial

Guidant''s Leadership in Heart Failure Therapy Continues with Landmark Study

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced its exclusive sponsorship of the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). The new trial will follow in the tradition of two previous landmark defibrillation implantation trials, MADIT and MADIT II, each exclusively sponsored by Guidant. The results of these trials led to breakthroughs in the prevention of sudden cardiac death (SCD).

* MADIT: Proved for the first time that prophylactic implantable cardioverter defibrillator (ICD) therapy can dramatically improve survival in high-risk patients. As a result of MADIT, patients no longer had to experience a life-threatening arrhythmia in order to qualify for, and receive the lifesaving benefits of, ICD therapy.
* MADIT II: Proved heart attack survivors with impaired heart function (EF <30%), without any other risk stratification, benefit from ICD therapy. As a result of MADIT II, patients no longer have to undergo invasive electrophysiological testing to receive the lifesaving benefits of ICD therapy.
* MADIT-CRT: Designed to test whether cardiac resynchronization therapy defibrillators (CRT-D) will slow the progression of heart failure in heart attack survivors with impaired heart function. The trial will determine if earlier intervention with CRT-D therapy can slow a patient''s progression from early stage heart failure (NYHA Class I-II) to late stage heart failure (NYHA Class III-IV).

Approximately 70 percent of all heart failure patients fall into NYHA Class I or II. Nearly 22 million people worldwide, including approximately 5.5 million Americans, currently suffer from heart failure. Nearly one million new cases of heart failure are diagnosed annually worldwide, making it the most rapidly growing cardiovascular disorder.

MADIT-CRT will also measure the expected beneficial economic impact of CRT-D therapy to the healthcare system. Heart failure is the leading cause of hospitalization for people age 65 and older, and represents the number one cost to the healthcare system. Heart failure is a debilitating condition that affects not only a patient''s quality of life, but also life expectancy. It is a condition in which the heart weakens and gradually loses the ability to pump blood effectively.

Like MADIT and MADIT II, the MADIT-CRT trial will be conducted under the leadership of principal investigator Dr. Arthur J. Moss professor of Medicine at the University of Rochester. Dr. Moss leads a world-renowned research organization at the University of Rochester, which has been responsible for more than 25 clinical studies bridging basic science, pharmaceutical and medical device therapies.

"This study builds upon the observations made in the COMPANION trial, which evaluated the benefits of CRT-D therapy in patients with late-stage, symptomatic heart failure (NYHA Class III-IV)," said Dr. Arthur Moss. "MADIT-CRT will answer a frequently asked and critically important question about the potential of resynchronization defibrillator therapy to intervene earlier in the natural history of heart failure progression (NYHA Class I-II)."

The MADIT-CRT executive committee is finalizing the study design and is preparing documents for submission to the U.S. Food and Drug Administration (FDA). Recruitment of additional sites and investigators will begin in 2004. Study enrollment is expected to exceed 1,500 patients over a period of approximately two years, with an average follow-up of 30 months.

"Through sponsorship of landmark clinical trials, such as the recently completed COMPANION trial, Guidant demonstrates leadership in clinical science and a commitment to evidence-based medicine," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "We continue to invest in innovative research, development, and clinical science to create beneficial therapies for heart failure patients and drive market development in this important field of medicine."

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 11,000 employees, 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.

This release includes forward-looking statements concerning the clinical trial. The statements are based on assumptions about many important factors, including regulatory timelines, continuing clinical and other developments, and factors identified on Exhibit 99 to the company''s most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.