Nov 20, 2001
Guidant Notified that Landmark Implantable Defibrillator Study Ends Early

MADIT II Study Stopped Due to 30 Percent Mortality Reduction in Heart Attack Survivors with Implantable Defibrillators

Indianapolis, IN and St. Paul, MN - The MADIT II investigative team today announced the early termination of the Multi-center Automatic Defibrillator Implantation Trial (MADIT II). The study was terminated early by the study's independent data and safety monitoring board (DSMB) due to significantly improved total survival for those heart attack survivors receiving an implantable defibrillator compared to those receiving conventional treatment.

The MADIT II trial was a prospective, randomized, multi-center study that enrolled more than 1,200 patients in 71 centers in the United States and five European centers. The study was supported solely by a research grant from Guidant Corporation. The study was designed to determine whether Guidant implantable defibrillators improve survival when compared to drug therapy alone in heart attack survivors with moderate impairment of the left ventricle, the heart's main pumping chamber. Arthur J. Moss, M.D., at the University of Rochester Medical Center, was the principal investigator of the study. Data collection and analysis was managed by a data and safety monitoring board independent of Guidant Corporation and the investigators.

The study was stopped because the use of an implantable defibrillator dramatically reduced mortality from sudden cardiac death (SCD) in patients who have survived heart attacks and have weakened hearts. SCD is the abrupt loss of heart function, usually due to a potentially fatal electrical rhythm dysfunction called ventricular fibrillation. SCD claims the lives of nearly 400,000 Americans annually. More people die in the United States each year from sudden cardiac death than from lung cancer, breast cancer and AIDS combined.

"MADIT II is a landmark study that demonstrates the further benefit of implantable defibrillator therapy. Previous trials, including MADIT, MUSTT and AVID, have demonstrated that implantable defibrillators improve survival in other patient populations. In this study, implantable defibrillators reduced mortality by 30 percent," according to Dr. Moss. Complete study findings will be published by the investigative team in the near future.

Under current FDA-approved indications, 300,000 patients each year in the United States are eligible to receive an implantable defibrillator. Guidant plans to submit for an expanded indication to the FDA that, if approved, could potentially double the eligible patient population.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to 7 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 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.

This release contains forward-looking statements about the company's future financial results, the company's prospects and products in research and development. This information is based upon management's current expectations, but actual results may differ materially from those discussed in the forward-looking statements. Other factors affecting future results include those outlined in Exhibit 99 to the company's Form 10-Q for the quarter ending September 30, 2001.