Jul 8, 2003
Guidant Announces U.S. Approval of Next Generation Heart Failure Therapy System

Cardiac Resynchronization Therapy-Defibrillator Represents the World''s Most Advanced System

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 of its next-generation cardiac resynchronization therapy defibrillator (CRT-D)'"the CONTAK® RENEWAL(tm) 3 system. This new system builds on Guidant''s highly successful RENEWAL family of heart failure therapy devices.

"Physicians appreciate Guidant CRT-D flexibility in tailoring therapy for their patients. The RENEWAL 3 CRT-D offers this advantage as well as a full suite of diagnostic and therapy options in a smaller, physiologic teardrop shape," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "The RENEWAL 3 CRT-D'"our third new heart failure device in the last ten months'"continues Guidant''s remarkable delivery of new products for the treatment of heart failure."

The RENEWAL 3 CRT-D is specifically designed for heart failure patients and is placed beneath the skin, near the collarbone, to monitor heartbeats and assist as needed. It delivers small electrical impulses that may improve the timing of the heart and its pumping ability. The system contains enhanced patient-focused diagnostic capabilities intended to help the clinician understand the patient''s changing condition and customize therapy. Guidant's RENEWAL family includes the first and only CRT-D devices commercially available in the United States that use independent sensing and independent electrical stimulation to deliver appropriate therapy to both the left and right ventricles. The RENEWAL 3 CRT-D family also includes a high-energy option for patients who require additional energy to resume normal heart rhythm.

Heart failure is a debilitating condition that affects not only a patient''s quality of life, but also life expectancy. It is a disease in which the heart weakens and gradually loses the ability to pump blood effectively. Nearly 22 million people worldwide, including approximately five million Americans, currently suffer from heart failure. Additionally, nearly one million new cases of heart failure are diagnosed annually worldwide, making it the most rapidly growing cardiovascular disorder.

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.
About the CONTAK RENEWAL 3 CRT-D

The CONTAK RENEWAL 3 CRT-D is Guidant''s next generation device specifically designed for the treatment of heart failure. The RENEWAL 3 CRT-D features independent channels and, at 37 cc in volume and 11.5 mm thin, is the smallest, thinnest CRT-D available on the U.S. market today. The physiologic teardrop shape makes the device easy to implant and is intended to provide increased comfort for patients. As with other RENEWAL CRT-D systems, the RENEWAL 3 system includes Guidant''s proprietary Heart Rate Variability (HRV) Monitor Footprint, a unique way to visualize the patient''s heart rate and frequency over the previous 24 hours. The HRV Monitor Trending feature enables the physician to monitor a heart failure patient''s cardiac activity over time.

THE RENEWAL 3 CRT-D also includes Guidant''s proprietary Ventricular Rate Regulation (VRR) feature. The VRR feature is designed to maximize the delivery of resynchronization therapy in the presence of atrial fibrillation, an irregular fast rhythm in the upper chambers of the heart that is present in as many as 50 percent of NYHA Class IV heart failure patients. This feature promotes CRT therapy during episodes of atrial fibrillation.

The new CRT-D includes a high-energy option and new capacitor technology, which provides a 39 percent reduction in charge times. The RENEWAL 3 CRT-D family also offers physicians a choice of models with either an IS-1 or LV-1 port size for use with the EASYTRAK lead. Multiple models provide physicians with additional options during implant.

Full U.S. commercial launch of the CONTAK RENEWAL 3 CRT-D system will occur later this quarter.
About Guidant''s Leadership in Heart Failure Therapy

Lifesaving therapy, such as the RENEWAL 3 CRT-D, is available today as a result of Guidant''s continued commitment to clinical science and research and development in heart failure. More than 13 years and $350 million have been invested to date. As a leader in technical innovation, Guidant is providing heart failure patients and the physicians who treat them with device-based solutions designed to extend and improve life. In May 2002, Guidant was the first company to receive approval in the United States to market cardiac resynchronization therapy defibrillators (CRT-D). Guidant is advancing clinical science by sponsoring landmark studies such as the Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. Preliminary results of the COMPANION trial were presented at the American College of Cardiology (ACC) 52nd Annual Scientific Session in March 2003. Guidant sponsored clinical research and development in the area of heart failure continues to advance heart failure therapies and provide answers to critical clinical questions about long-term treatment outcomes for cardiovascular disease. Guidant continually works with government agencies, elected officials, physicians and patient advocacy groups to help ensure timely access to new technologies for the patients who will benefit from these medical innovations.