Sep 25, 2002
Guidant Commends New Guideline for Defibrillator Implants

New Guideline Reflects Results of MADIT II Trial

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced that it commends the new guideline for the use of implantable defibrillators (ICDs). The new guideline was published yesterday by a joint committee from the American College of Cardiology (ACC), the North American Society of Pacing and Electrophysiology (NASPE) and the American Heart Association (AHA).

"Guidant applauds the leadership of NASPE, ACC and AHA toward adoption of the findings of the MADIT II study," said Fred McCoy, president, Cardiac Rhythm Management, Guidant. "The new guidelines directly reflect results of the Guidant-sponsored Multicenter Automatic Defibrillator Implantation Trial (MADIT) II. The committee''s special effort to include MADIT II patients in this current round of guideline revisions is a great service to this patient population."

The new guideline states that heart attack survivors with an ejection fraction of less than or equal to 30 percent (the same criteria used for the MADIT II trial) are recommended for an implantation of an ICD for primary prevention of sudden cardiac death (SCD). 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.

Approximately 10 to 15 percent of the 1 million annual U.S. heart attack survivors meet the MADIT II criteria and would be indicated for an implantable defibrillator under the newly released guideline. The new guideline was classified as IIa, meaning that, while there is a divergence of opinion, the weight of evidence and opinion is in favor of the usefulness and efficacy of the implantable defibrillator for this patient population.

An independent Data Safety Monitoring Board halted the MADIT II trial in November 2001 because data showed a 31 percent decrease in mortality for those patients receiving an implantable defibrillator versus those receiving drug therapy alone. 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. Guidant is the only implantable defibrillator manufacturer to have approved labeling that includes the patient population defined by MADIT II. These milestones, coupled with yesterday''s release of a new implantation guideline, are acknowledgements of the trial''s strong and compelling data. Currently, the U.S. Center for Medicare and Medicaid Services (CMS) is weighing a national coverage decision for the MADIT II indication. Meanwhile, local fiscal intermediaries and carriers have the discretion to determine reimbursement. A CMS national coverage decision is expected this fall.

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.

See our special section for more information on the MADIT II study.