May 2, 2002
FDA Approves Guidant's System for the Treatment of Heart Failure

Only Approved Technology to Treat Both Sudden Cardiac Death and Heart Failure; Guidant to Hold Webcast Conference Call Today

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 the U.S. Food and Drug Administration (FDA) has approved the CONTAK CD®/EASYTRAK® system for the treatment of heart failure. It is the first system approved that combines an implantable defibrillator with cardiac resynchronization therapy (CRT-D).

"Today's FDA approval reaffirms Guidant's leadership in device-based therapy for the treatment of heart failure. We will immediately launch this pioneering therapy for the thousands of people in the United States who will benefit from both cardiac resynchronization therapy and the protection from sudden cardiac death," said Ronald W. Dollens, president and CEO, Guidant Corporation. "The approval offers heart failure patients and physicians new hope as they battle this debilitating disease."

The CONTAK CD CRT-D device addresses the two primary concerns of physicians who treat heart failure patients-improving their quality of life and protecting them from sudden cardiac death (SCD). The CRT function of the device helps the chambers of the heart beat in a coordinated manner, improving a heart failure patient's functional capabilities. The implantable defibrillator function corrects potentially life-threatening rapid heart rhythms, preventing sudden cardiac death. Half of all heart failure deaths are a result of end-stage, progressive pump failure, and the other half are due to sudden cardiac death.

"The approval of our CONTAK CD/EASYTRAK system greatly accelerates our ability to treat heart failure patients who are at risk for sudden cardiac death," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "Guidant has an outstanding, well-trained field force, a dedicated physician training program and a high-quality device-based therapy. This industry leading combination immediately positions us exceptionally well to help those who suffer from heart failure."

Heart failure currently affects nearly five million Americans and is increasing each year in both prevalence and incidence. Heart failure is a progressive cardiac illness in which the heart cannot pump enough oxygenated blood to meet the body's needs. In many cases, this inefficient pumping occurs because the four chambers of the heart are not working as a team. The timing, or synchrony, between the chambers is often poor. Consequently, the chambers do not fill and empty normally, so the heart's pumping efficiency is compromised.

The new device is also distinguished by an innovative lead - called the EASYTRAK lead. The EASYTRAK lead, in conjunction with leads implanted in the right side of the heart, allows the CONTAK CD pulse generator to sense and stimulate both the left and right sides of the heart. The EASYTRAK lead design is the first to allow the physician to position the electrode in a vein on the left side of the heart using a convenient over-the-wire technique similar to the system used in angioplasty procedures. The EASYTRAK lead system demonstrated in clinical trials a low incidence of dislodgement or migration, allowing for better therapy and more precise sensing and stimulation of the left ventricle.

This device approval follows an unrelated landmark clinical trial - named MADIT II - sponsored by Guidant that was published in March in The New England Journal of Medicine. The MADIT II trial demonstrated that patients with a prior heart attack and compromised heart function who received an implantable defibrillator experienced a 31 percent reduction in mortality, compared to patients with optimal drug therapy alone.

Conference Call/Webcast

Guidant will conduct a live webcast conference call today, , at 5 p.m. (EDT) to further discuss the FDA's approval of the CONTAK CD/EASYTRAK system. The live webcast of Guidant's conference call will be accessible through Guidant's website or at CCBN's individual investor center. The webcast will be archived on both websites for future on-demand replay.

System requirements for the webcast include Internet Explorer 5.0 (or higher) or Netscape Navigator 4.0 (or higher). Users also should have the most recent version of Windows Media Player, which can be downloaded for free. Users may experience varying levels of performance based on their connection speed, system capabilities and presence of a corporate firewall. To ensure a connection, users should go to the program five to 15 minutes before its start.

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.

This release includes financial guidance, the timing of regulatory filings and approvals and expanded indications for Guidant's products. The statements are based on assumptions about many important factors, including the results of product trials, internal FDA processes and timelines, product and market development, competition, litigation, foreign exchange and the factors listed on exhibit 99 to Guidant's most recent 10-K. As such, they involve risks that could cause actual results to differ materially. The company does not undertake to update its forward-looking statements.