Jan 29, 2004
Guidant Announces U.S. Launch of Cardiac Resynchronization Therapy Pacemaker

Guidant Receives FDA Approval Based on COMPANION Clinical Trial Data

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced U.S. Food and Drug Administration (FDA) approval and the U.S. market launch of its cardiac resynchronization therapy pacemaker (CRT-P)'"the CONTAK ® RENEWAL(tm) TR. This new CRT-P system builds on Guidant''s highly successful RENEWAL family of heart failure therapy devices. The RENEWAL TR CRT-P includes independent pacing and sensing in the right and left ventricles, as well as advanced programming options that assist clinicians in adjusting therapy to better meet the needs of individual patients.

The RENEWAL TR CRT-P is specifically designed for patients who struggle with heart failure. This system is designed to deliver small electrical pulses that may synchronize the timing of the heart and improve its pumping ability. RENEWAL TR includes enhanced patient diagnostics that measure and record the heart''s electrical activity, which helps clinicians review therapy history and arrhythmia events.

"The RENEWAL TR is an important addition to Guidant''s CRT portfolio," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "Our cardiac resynchronization therapies provide physicians innovative options for their heart failure patients."

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. Nearly five million Americans and more than six million Europeans 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. Analysts estimate the worldwide CRT-P market to be near $300 million dollars in 2004.

Guidant''s landmark COMPANION trial provided the pivotal clinical support for RENEWAL TR based on cardiac performance, exercise capability and quality of life data. Guidant devices were studied exclusively in the COMPANION trial and the RENEWAL TR CRT-P has now been FDA approved as safe and effective in this population.

Guidant has also submitted data from the COMPANION trial to expand existing labeling for the RENEWAL CRT-D family of devices for the COMPANION patient population. Additionally, results of the COMPANION trial continue on track for publication in an upcoming issue of a major peer-reviewed medical journal.

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 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 CRT-P and CRT-D. The statements are based on assumptions about many important factors, including market development for CRT-P, regulatory timelines and approvals and other 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.