Guidant's Heart Failure Therapy Unanimously Recommended for a Broader Patient Population

Business Wire, July 28, 2004

INDIANAPOLIS, Ind. and ST. PAUL, Minn. -- U.S. Food and Drug Administration Advisory Committee Approval Based on Data from Company's Landmark COMPANION Heart Failure Trial

Guidant Corporation (NYSE:GDT) today announced that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) has unanimously recommended approval, with conditions, of expanded user labeling, including indications, for its cardiac resynchronization therapy defibrillators. The FDA will now consider the Panel's recommendation prior to making its final decision. Pending approval, thousands of additional heart failure patients would be eligible for this lifesaving therapy.

"Today's recommendation is the result of an exhaustive review of the data generated by this important study. COMPANION results demonstrate the value of cardiac resynchronization therapy defibrillators in a broader group of heart failure patients," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "We now look forward to the Food and Drug Administration's final decision."

The Advisory Panel, in an 8 to 0 vote, recommended expanded indications and labeling approval, with conditions, for Guidant's cardiac resynchronization therapy defibrillators in the entire COMPANION population.

Guidant is seeking indications and usage labeling that reflects the studied population in the landmark Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) trial. Results of the COMPANION trial were published in the May 20, 2004 issue of the New England Journal of Medicine. The COMPANION trial included 1,520 heart failure patients from 128 clinical trial sites across the United States. Trial results achieved the primary endpoint of a risk reduction for events consisting of either time to death or first hospitalization, for any cause, following implant of cardiac resynchronization therapy pacemakers or defibrillators. Additionally, treatment with resynchronization therapy defibrillators demonstrated a 36 percent reduction in all-cause mortality.

Guidant Corporation is a world leader in the treatment of cardiac and vascular disease. The company pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. Driven by a strong entrepreneurial culture of 12,000 employees, Guidant 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

NOTE TO MEDIA: For more information about Guidant, including products, services and patient profiles, please visit the company's newsroom at www.guidant.com/newsroom.>

COPYRIGHT 2004 Business Wire

COPYRIGHT 2008 Gale, Cengage Learning