Feb 12, 2003
Guidant Applauds Recommendation for Nationwide Medicare Coverage for Defibrillator Implants

Medicare Coverage Advisory Committee Recommends Expanding Coverage to Include MADIT II Patients

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today reported that the Medicare Coverage Advisory Committee (MCAC) recommended to expand coverage for the use of implantable defibrillators (ICDs). The committee''s recommendation, if adopted by the Centers for Medicare and Medicaid Services (CMS), will clearly provide for Medicare coverage of ICD therapy for those patients identified by the recent Multicenter Automatic Defibrillator Implantation Trial (MADIT) II. The recommendation followed discussion at an MCAC meeting held earlier today, where the committee voted unanimously (7 to 0) that MADIT II evidence supports Medicare coverage. Guidant anticipates that CMS will consider this recommendation and issue a final coverage decision in 30 to 90 days. Meanwhile, local fiscal intermediaries of Medicare continue to exercise independent discretion over coverage for the patients who fit the MADIT II criteria.

"At its completion, MADIT II was the largest in a series of Guidant sponsored, independently conducted, randomized, controlled trials. Guidant requested a national coverage decision based on the strength of the trial results. We are gratified that the committee unanimously recommended a positive national coverage decision by CMS," said Fred McCoy, president, Cardiac Rhythm Management, Guidant. "The Medicare Coverage Advisory Committee''s recommendation affirms the pivotal role of sound clinical research for policy decisions."

The committee''s recommendation supports the use of implantable cardiac defibrillators as "reasonable and necessary" therapy for all Medicare patients who meet the inclusion and exclusion criteria of the MADIT II trial.

The MCAC is advisory in nature. It is comprised of clinicians and other medical experts as well as non-voting industry and consumer representatives. It determines if there is adequate evidence to support a request for coverage and makes a recommendation to CMS. Final decisions related to national medical coverage policies rest solely with CMS.

An independent Data Safety Monitoring Board halted the MADIT II trial in November 2001 because the study demonstrated a 31 percent decrease in mortality for those patients receiving an implantable defibrillator compared to 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.

On September 24, 2002, 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) published updated physician practice guidelines that recommend the use of implantable defibrillators for patients meeting the MADIT II criteria. Most recently, the European Society of Cardiology updated its guideline for defibrillator implants to include MADIT II patients. The quality and conclusions of the MADIT II study have also been endorsed by the Technical Evaluation Committee of Blue Cross Blue Shield and by other private insurers, representing more than 100 million covered lives.

"I am pleased by MCAC''s decision, since the clinical trial data clearly indicate the lifesaving nature of ICD therapy in patients with a prior heart attack and compromised heart function," said Arthur J. Moss, M.D., professor of medicine and director of the Heart Research Follow-Up Program and primary investigator of MADIT II at the University of Rochester Medical Center, Rochester, NY.

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.

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

This release includes forward-looking statements concerning the timing of coverage decisions relating to the Company's products. The statements are based on assumptions about many important factors, including the ultimate decision of CMS, given that the MCAC is advisory in nature and the factors listed on exhibit 99.1 to Guidant''s most recent 10-Q. As such, they involve risks that could cause actual results to differ materially. The company does not undertake to update its forward-looking statements.