Sep 15, 2004
Guidant Receives Exclusive Expanded Indication for Heart Failure Treatment

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE: GDT) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for the company''s portfolio of cardiac resynchronization therapy defibrillators (CRT-D). The expanded indication makes Guidant''s cardiac resynchronization therapy defibrillators available to thousands more heart failure patients, helping them live both better and longer.

The expanded indication, effective immediately, is based on results from the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Trial, sponsored solely by Guidant. Guidant is the only manufacturer to have its cardiac resynchronization therapy defibrillators indicated for the entire COMPANION heart failure patient population.

Guidant cardiac resynchronization therapy defibrillators are now indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (an ejection fraction less than or equal to 35 percent) and QRS duration of greater than or equal to 120 milliseconds. Previously, patients were required to be indicated for both an implantable cardioverter defibrillator and resynchronization therapy in order to receive a cardiac resynchronization therapy defibrillator. This expanded indication means heart failure patients no longer need to have an implantable defibrillator indication to receive the benefits of a Guidant cardiac resynchronization therapy defibrillator.

"Approval from the FDA to expand indications for Guidant cardiac resynchronization therapy defibrillators further demonstrates the scientific strength of the COMPANION study," said Dr. Joseph Smith, chief medical officer, Cardiac Rhythm Management, Guidant Corporation. "This new indication allows physicians to extend the lifesaving and life-enhancing benefits of CRT-D therapy to a broader group of patients struggling daily with the burdens of moderate to severe heart failure."

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. Heart failure patients are at significant risk for sudden cardiac death. On average, about 50 percent of heart failure patients die of lethal arrhythmias, or sudden cardiac death.