Jan 24, 2003
Guidant Commends New European Guideline for Defibrillator Implants

Enhanced Guideline Reflects Results of MADIT II Trial

Indianapolis, Ind. and Brussels, Belgium - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced that it commends the new European guideline for the use of implantable cardioverter defibrillators (ICD). The new guideline reflects the results of the Guidant-sponsored Multicenter Automatic Defibrillator Implantation Trial (MADIT) II. The new guideline was published in the January issue of the European Heart Journal by a taskforce from the European Society of Cardiology (ESC) and can be viewed at www.escardio.org/scinfo/Guidelines/02_update_scd.pdf.

The new guideline states that heart attack survivors with an ejection fraction of less than or equal to 30 percent (the same criteria studied in the MADIT II trial) are recommended for an implantation of an ICD for primary prevention of sudden cardiac death (SCD). The new guideline was classified as IIa, meaning that the weight of evidence is in favor of the usefulness and efficacy of the implantable defibrillator for this patient population. Ejection fraction is the measurement of how effectively the heart is pumping blood. People with healthy hearts have an ejection fraction of 50 percent or greater.

"Guidant applauds the leadership of the European Society of Cardiology and the taskforce led by Dr. Silvia Priori from the University of Pavia, Italy," said Fred McCoy, president, Cardiac Rhythm Management, Guidant. "The taskforce''s inclusion of MADIT II patients in the ESC guideline enhancement is further affirmation of the lifesaving benefit of ICD therapy."

An independent Data Safety Monitoring Board halted the MADIT II clinical trial in November 2001 because the trial demonstrated a 31 percent decrease in mortality for those patients receiving an implantable defibrillator versus those receiving optimal drug therapy alone. MADIT II trial results were published in the March 21, 2002, New England Journal of Medicine. On July 18, 2002, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Guidant implantable defibrillators based on the MADIT II trial results. On September 24, 2002, a joint committee from the American College of Cardiology, the North American Society of Pacing and Electrophysiology and the American Heart Association published updated physician practice guidelines, classified as IIa, that recommend the use of implantable defibrillators for patients meeting the MADIT II criteria.

"Earlier trials such as MADIT and MUSTT have demonstrated a significant impact on clinical practice around the world. MADIT II, with its compelling data and straightforward indications, is expected to continue this trend," said Professor Helmut Klein, Head of the Cardiology Unit of the Otto von Guericke University in Magdeburg, Germany, and one of the European investigators in the MADIT II trial.

Guidant has a strong heritage of sponsoring landmark clinical trials designed to answer critical clinical questions concerning long-term treatment outcomes for cardiovascular disease. Guidant sponsored trials include COMPANION, MADIT II, MADIT, MUSTT and CADILLAC.

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 more than 10,000 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 and www.madit2.com.

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