Jul 1, 2004
Guidant Provides Update on its CHAMPION Drug Eluting Stent Program

Indianapolis, Ind. - Guidant Corporation (NYSE: GDT) will host its previously announced conference call today, , at 4:30 PM EDT. On the call, the company will provide an update on its lead drug eluting stent program, the CHAMPION(tm) Everolimus Eluting Coronary Stent System.

In late May, Guidant disclosed issues relating to the stainless steel stent platform of its CHAMPION Everolimus Eluting Coronary Stent System. The issues occurred in a limited number of stents implanted in preclinical studies. As a result, the stainless steel stent platform did not meet Guidant''s internal performance or quality standards, leading the company to delay its regulatory filings for the product. After further testing and evaluation over the last several weeks, the company has identified a combination of changes in material processing and stent design that improves the stainless steel stent platform and addresses performance and quality concerns.

The safety and efficacy of the everolimus eluting stent with bioabsorbable polymer is supported by excellent 12-month clinical data as reported in the FUTURE I and FUTURE II trials.

Guidant met recently with the U.S. Food and Drug Administration (FDA) and European regulatory authorities to discuss its findings and its plan to resolve the issues. The plan is structured so that, upon completion of improvements to the stainless steel stent platform, and following standard stent performance testing and validations, no additional clinical data would be required. In addition, the FUTURE I and FUTURE II clinical trial data would continue to be the only clinical data required to support European approval and the commencement of the company''s U.S. pivotal trial, FUTURE IV. Both regulatory bodies concurred with the company''s test methodology and its plan.

As also previously disclosed in May, the company is refining its processes to support large-scale manufacturing.

Improvements to the stainless steel stent platform and the refinement of manufacturing processes are expected to result in a six-to-eight month program delay, while the company completes these refinements and standard stent performance testing and validations. The company now expects to file an Investigational Device Exemption (IDE) application with the FDA in the first quarter of 2005 and to launch the CHAMPION Everolimus Eluting Coronary Stent System in Europe in mid-2005.

Conference Call

Participating on the call will be Guido J. Neels, chief operating officer, Guidant Corporation and Dana G. Mead, Jr., president, Vascular Intervention, Guidant Corporation.

A live webcast of Guidant''s conference call will be accessible through the company''s website at www.guidant.com/webcast. The webcast will be archived for future on-demand replay. Additional financial information concerning Guidant is available at www.guidant.com/investors.

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 12,000 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.

This release includes forward-looking statements concerning DES product timelines, the resolution of issues relating to the CHAMPION platform, and the DES program generally. The statements are based on assumptions about many important factors, including additional clinical reviews and work, associated regulatory processes and timelines, additional operational enhancements, and other factors identified on Exhibit 99 to the company''s most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.