Jun 6, 2003
Guidant-sponsored Implantable Defibrillator Trials Result in Expanded Medicare Coverage

CMS Decision Leaves Some Seniors Without Coverage for Now

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today reported that the Centers for Medicare and Medicaid Services (CMS) has announced its intent to expand national coverage for the use of implantable defibrillators (ICDs) for patients with a previous heart attack, left ventricular ejection fraction ≤30%, and QRS duration greater than 120 milliseconds. This patient group represents a sub-population of the second Multicenter Automatic Defibrillator Implantation Trial (MADIT II). Further, the decision clarifies that Medicare national coverage extends to the landmark MADIT I trial population, also solely sponsored by Guidant.

"This decision extends Medicare ICD coverage to many MADIT II patients, thereby expanding the number of people who will receive the life-saving benefits of ICDs and providing for sustainable growth of ICD therapy. However, best medical science and evidence-based medicine signal us that this coverage stops short of that which is warranted. The scientific data convincingly demonstrate that, in patients who meet the MADIT II criteria, implantable defibrillators offer life-saving benefits," said Fred McCoy, president, Cardiac Rhythm Management, Guidant. "We encourage CMS to follow through on its stated commitment to evaluate national coverage in the remainder of the MADIT II population as additional data becomes available."

On February 12, 2003, CMS convened its Medicare Coverage Advisory Committee (MCAC) to provide impartial expert review of the MADIT II trial evidence. All associated evidence was fully scrutinized, including a detailed analysis of whether QRS duration offered any significant risk stratification in the MADIT II population. In consideration of all the evidence and discussion, the committee voted 7 to 0 that the evidence is adequate to apply the findings of the MADIT II trial to all Medicare patients who meet the trial''s inclusion and exclusion criteria.

"CMS''s limited coverage decision is inconsistent with the findings of the MADIT II trial, which demonstrated a significant reduction in the risk of death for all patients who received ICD therapy," 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, N.Y. "Today''s decision ignores published practice guidelines, which are based on clinical trial evidence."

"The science of the MADIT II trial remains clear. There is no identifiable subgroup of MADIT II type patients who failed to benefit from ICD therapy," said Joseph M. Smith, M.D., Ph.D., F.A.C.C., senior vice president and chief medical officer, Cardiac Rhythm Management, Guidant. "This decision deprives a significant number of seniors Medicare coverage for the life-saving benefits of ICD therapy."

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 11,000 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.
What is QRS?

QRS duration is the measured duration of electrical activation of the heart''s two main pumping chambers. It can be measured on a routine ECG (electrocardiogram). Normal QRS durations are typically less than 100 milliseconds. Prolonged QRS durations have become associated with various forms of heart disease and adverse cardiac outcomes.
About MADIT II

MADIT II was a prospective, randomized, multi-center intention-to-treat study that enrolled 1,232 patients at 71 centers in the U.S. and five outside the U.S. The study was designed to determine whether the implantable cardioverter defibrillator (ICD), in combination with optimal drug therapy, prevents more deaths than optimal drug therapy alone in heart attack survivors with moderate impairment of the heart''s main pumping chamber, the left ventricle.

To be included in the study, patients had to meet the following criteria:

* Male or female, 21 years old or older
* One or more myocardial infarction (heart attack) three weeks or more prior to enrollment.
* Left ventricular ejection fraction (EF) less than or equal to 30 percent.

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 provide for the use of implantable defibrillators for patients meeting the MADIT II criteria. Earlier this year, the European Society of Cardiologists issued new guidelines for defibrillator implants based on MADIT II trial results. After subjecting the data to intensive review, 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.

For more information about the MADIT II clinical trial, visit www.guidant.com/physician/madit/index.shtml.