Nov 20, 2002
National Coverage Decision for Implantable Defibrillators Referred to Medicare Coverage Advisory Committee

Indianapolis, Ind. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today reported that the Center for Medicare and Medicaid Services (CMS) announced that it would refer the MADIT (Multicenter Automated Defibrillator Implantation Trial) II coverage decision to their Medicare Coverage Advisory Committee (MCAC).

"Given the demonstrated lifesaving therapy of the implantable cardioverter defibrillator (ICD) and the corresponding benefit to Medicare beneficiaries, we commend CMS for their continued careful review of this clinical data," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "This is a positive development in that the referral to MCAC will provide an even broader group of clinicians and experts an opportunity to review the MADIT II trial scientific data and encourage CMS to provide consistent coverage of this important therapy for the Medicare population. Guidant looks forward to supporting the MCAC in its review." As this evaluation proceeds, local payment mechanisms will continue to allow patients access to this lifesaving ICD therapy.

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 issue of the 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 use of implantable defibrillators for patients meeting the MADIT II criteria.

The MCAC is advisory in nature, and consists of medical specialty panels and an Executive Committee. The panels are comprised of clinicians and other medical experts as well as non-voting industry and consumer representatives. Final decisions related to national medical coverage policies rest solely with CMS.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for a 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.