Jun 22, 2005
Guidant Begins Enrollment in U.S. Drug Eluting Stent Trial

Large-Scale Pivotal Trial to Evaluate Safety and Efficacy of Next-Generation XIENCE V Coronary Stent System

Indianapolis, Ind. - Guidant Corporation (NYSE: GDT) today announced that the company has begun enrollment in its SPIRIT III drug eluting stent clinical trial.

SPIRIT III is a large-scale pivotal clinical trial evaluating XIENCE(tm) V, an everolimus eluting coronary stent system utilizing Guidant''s cobalt chromium MULTI-LINK VISION® Coronary Stent System platform. This prospective, randomized, single-blind trial evaluates the safety and efficacy of XIENCE V compared to the TAXUS(tm) Express 2(tm) Paclitaxel Eluting Coronary Stent System for the treatment of coronary artery disease. Results of the SPIRIT III trial may be used to obtain FDA approval for XIENCE V for the treatment of coronary artery disease.

"The commencement of the SPIRIT III trial is a significant milestone for Guidant as it will allow us to advance the science of drug eluting stents, and brings us closer to offering this important therapy to physicians and patients worldwide," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant.

The first patients were enrolled by Mark Midei, M.D., F.A.C.C., Director, Catheterization Laboratory at St. Joseph''s Medical Center, Towson, Md.; Robert Applegate, M.D., Medical Director, Cardiac Catheterization Laboratory at Wake Forest University Baptist Medical Center, Winston-Salem, N.C.; and Daniel Simon, M.D., Associate Director of Interventional Cardiology at Brigham and Women's Hospital in Boston.

Gregg Stone, M.D., Professor of Medicine and Director of Cardiovascular Research and Education of Columbia University Medical Center in New York, and Campbell Rogers, M.D., Director of Cardiac Catheterization at Brigham and Women's Hospital, are co-principal investigators of the study.

Guidant also anticipates initiating the SPIRIT II clinical trial in Europe in the very near future.

Guidant's presence in U.S. drug eluting stents was achieved in February 2004 through an agreement with Cordis Corporation, a Johnson & Johnson company. Under the terms of the agreement, Guidant co-promotes Cordis'' CYPHER® Sirolimus-eluting Coronary Stent in the United States.

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.

NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company''s newsroom at www.guidant.com/newsroom.

This release includes forward-looking statements concerning XIENCE(tm) V. The statements are based on assumptions about many important factors, including satisfactory enrollment and completion of the clinical trial, associated regulatory processes and timelines, and other factors identified on Exhibit 99 to the company''s most recent filing on Form 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.