May 2, 2002
Guidant Initiates New International Paclitaxel Eluting Stent Trial

Largest Study to Date, DELIVER II Will Evaluate Clinical Benefit of ACHIEVE Stent in High-Risk Patients

Indianapolis, Ind. and Brussels - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced the enrollment of the first patient in a new clinical study designed to evaluate the benefit of the paclitaxel-coated ACHIEVE(tm) Drug Eluting Coronary Stent System in a broad population of patients, including high-risk patients and patients with complex lesions including in-stent restenosis. Data from this trial, which will be conducted on behalf of Cook Inc., may be used to expand indications for the ACHIEVE Stent System beyond those outlined in Cook's ASPECT and ELUTES trial protocols.

The clinical trial, called DELIVER II, will be the largest drug eluting stent trial to date, with a target enrollment of 1,500 patients in 100 centers outside the United States. The study will follow patients implanted with the ACHIEVE Stent System for a period of up to three years. The primary endpoint of the study is the target lesion revascularization rate, a measure of long-term clinical success. The study also will report on a number of secondary endpoints including safety, device success and cost effectiveness.

"We anticipate gaining greater knowledge of this potentially promising therapy with this major new trial, which is a part of a broad clinical trial strategy for fully understanding the benefits of drug eluting stents," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "We look forward to sharing the results with the medical community."

"I am very proud to be involved with this landmark trial with Guidant," said Prof. Eberhard Grube from the Herzzentrum Siegburg, principal investigator for the study. "The innovative design of the trial will create a wealth of information that should greatly increase our knowledge of the potential of drug eluting stents for treating patients with complex lesions. I am confident that the combination of the proven efficacy of the paclitaxel compound and the utilization of the state-of-the-art MULTI-LINK PENTA(tm) stent design will lead to outstanding results."

The first patient, who presented with in-stent restenosis, was treated with the ACHIEVE Stent System during a live case session at the Course on New Therapeutical Developments and Interventional Cardiology organized by Prof. Carlos Macaya in Madrid, Spain. Prof. Macaya, principal investigator for the Hospital Clínico San Carlos in Madrid, is a member of the steering committee for the DELIVER II Clinical Trial. Dr. Rosana Hernandez performed the first implant.

DELIVER, the first clinical study of the ACHIEVE Stent System, enrolled 1,043 patients in less than four months. The study is designed to serve as the basis for Guidant's submission for U.S. Food and Drug Administration (FDA) approval of the ACHIEVE Stent System on behalf of Cook Incorporated.

The ACHIEVE Drug Eluting Coronary Stent is manufactured by Cook Incorporated utilizing its proprietary paclitaxel drug coating and manufacturing processes, and incorporates components supplied by Guidant. Guidant is the worldwide exclusive distributor for the ACHIEVE Stent System.

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.