Nov 9, 2003
Guidant Receives Exclusive Expanded Indication for Heart Failure Treatment

MADIT II patients with heart failure now eligible for Cardiac Resynchronization Therapy Defibrillator

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has expanded indications for the company''s portfolio of cardiac resynchronization therapy defibrillators (CRT-D). The expanded indication makes CRT-D systems available to more heart failure patients, helping them live better and live longer. This expanded indication is based on results from the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II, sponsored by Guidant, and is effective immediately.

The indication now includes the prophylactic use of Guidant CRT-D systems for patients with late-stage, symptomatic heart failure (NYHA Class III-IV) who have had a previous heart attack and have an ejection fraction that is less than or equal to 30 percent. Ejection fraction is a measure of how efficiently the heart pumps blood. A level of 30 percent or less is an indication of impaired function that puts heart attack survivors at increased risk for sudden cardiac death.

"Approval from the FDA to expand indications for CRT-D systems based on MADIT II data is yet another demonstration of the scientific strength of this clinical trial," commented Dr. Joseph Smith, chief medical officer, Cardiac Rhythm Management, Guidant. "The expanded indication for this combination device allows more patients access to the improved quality of life afforded by resynchronization therapy as well as protection from the lethal arrhythmias which too often accompany heart failure."

Heart failure patients are at significant risk for sudden cardiac death (SCD). On average, about 50 percent of heart failure patients die of lethal arrhythmias, or sudden cardiac death. Previously, CRT-D therapy was reserved for those heart failure patients whose risk for sudden cardiac death was demonstrated by spontaneous or induced arrhythmias.

"Guidant''s pioneering work as a sponsor of the MADIT II Trial continues to pay dividends for physicians and their patients," said Fred McCoy, president, Cardiac Rhythm Management, Guidant. "This expanded FDA indication enables physicians to provide care for a broader group of heart failure patients also at known risk for sudden cardiac death."

Guidant is the only manufacturer in this industry to provide data to demonstrate its devices are clinically proven to be safe and effective by specifically studying MADIT II patients, and is the only company to have FDA approved specific labeling for both ICD and CRT-D systems for this patient population.

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 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.

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.