GDT Guidant Corp

Guidant Corporation (NYSE:GDT) today announced that the company has completed enrollment of 1,002 patients in the randomized U.S. portion of its SPIRIT III drug eluting stent pivotal clinical trial. The randomized U.S. cohort will support Guidant's Premarket Approval submission to the U.S. Food and Drug Administration (FDA) for the company's XIENCE(TM) V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. SPIRIT III is an international clinical trial consisting of a 1,002-patient prospective, randomized, single-blind U.S. cohort evaluating the safety and efficacy of the XIENCE V Everolimus Eluting Coronary Stent System compared to the TAXUS(R) Express 2(TM) Paclitaxel-Eluting Coronary Stent System for the treatment of coronary artery disease, and four non-randomized trial arms. The trial is being conducted in the U.S. and Japan. XIENCE V, which utilizes Guidant's proven MULTI-LINK VISION(R) cobalt chromium stent platform, received CE Mark approval in January and will be launched in Europe in the second quarter of 2006. "The completion of enrollment in the randomized U.S. portion of the SPIRIT III trial is a significant milestone for Guidant and demonstrates the commitment of our employees and trial investigators to advancing the science of drug eluting stents," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant. "We are very pleased with the progress this represents for this next-generation drug eluting stent in the U.S." Gregg Stone, M.D., Professor of Medicine and Director of Cardiovascular Research & 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. Dr. Shigeru Saito, Director of Cardiology and Catheterization Laboratories, Shonan Kamakura Hospital, is the principal investigator for the Japan arm of the trial. "Based on the positive results of SPIRIT FIRST, Guidant's -olimus based XIENCE V Everolimus Eluting Coronary Stent System appears to hold great promise as a next-generation therapy for treating coronary artery disease," said Dr. Rogers. "We look forward to analyzing these data and sharing results of the trial early next year. We also look forward to continuing to examine how the XIENCE stent performs in diverse patient and lesion subsets in upcoming clinical studies." "We are excited that the SPIRIT III clinical trial has completed enrollment so smoothly and rapidly," said Dr. Stone. "The potential of this highly deliverable XIENCE V Stent System represents a welcome option for physicians caring for patients with coronary artery disease." In November, Guidant announced that SPIRIT II, a 300-patient, randomized clinical trial evaluating XIENCE V outside the U.S., had completed enrollment in only four months. The single-blind, prospective, randomized, non-inferiority study further evaluates the XIENCE V compared to the TAXUS(R) Express 2(TM) Paclitaxel-Eluting Coronary Stent System for the treatment of coronary artery disease. About XIENCE V The XIENCE V Everolimus Eluting Coronary Stent System utilizes Guidant's most advanced coronary stent system, the highly deliverable cobalt chromium MULTI-LINK VISION(R), which is available on the preferred rapid-exchange platform. Everolimus has been shown to reduce tissue proliferation in the coronary vessels following stent implantation. Guidant is ramping up manufacturing and building inventory to supply ongoing clinical trials and to support the European launch of XIENCE V beginning in the second quarter of 2006. Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company 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 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.