15.03.2006 19:29:00
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Guidant Completes Enrollment in Randomized U.S. Portion of Drug Eluting Stent Pivotal Trial; Large-Scale Trial Evaluating Safety and Efficacy of Next-Generation XIENCE(TM) V Coronary Stent System
SPIRIT III is an international clinical trial consisting of a1,002-patient prospective, randomized, single-blind U.S. cohortevaluating the safety and efficacy of the XIENCE V Everolimus ElutingCoronary Stent System compared to the TAXUS(R) Express 2(TM)Paclitaxel-Eluting Coronary Stent System for the treatment of coronaryartery disease, and four non-randomized trial arms. The trial is beingconducted in the U.S. and Japan. XIENCE V, which utilizes Guidant'sproven MULTI-LINK VISION(R) cobalt chromium stent platform, receivedCE Mark approval in January and will be launched in Europe in thesecond quarter of 2006.
"The completion of enrollment in the randomized U.S. portion ofthe SPIRIT III trial is a significant milestone for Guidant anddemonstrates the commitment of our employees and trial investigatorsto advancing the science of drug eluting stents," said John M. Capek,Ph.D., president, Vascular Intervention, Guidant. "We are very pleasedwith the progress this represents for this next-generation drugeluting stent in the U.S."
Gregg Stone, M.D., Professor of Medicine and Director ofCardiovascular Research & Education of Columbia University MedicalCenter in New York, and Campbell Rogers, M.D., Director of CardiacCatheterization at Brigham and Women's Hospital, are co-principalinvestigators of the study. Dr. Shigeru Saito, Director of Cardiologyand Catheterization Laboratories, Shonan Kamakura Hospital, is theprincipal investigator for the Japan arm of the trial.
"Based on the positive results of SPIRIT FIRST, Guidant's -olimusbased XIENCE V Everolimus Eluting Coronary Stent System appears tohold great promise as a next-generation therapy for treating coronaryartery disease," said Dr. Rogers. "We look forward to analyzing thesedata and sharing results of the trial early next year. We also lookforward to continuing to examine how the XIENCE stent performs indiverse patient and lesion subsets in upcoming clinical studies."
"We are excited that the SPIRIT III clinical trial has completedenrollment so smoothly and rapidly," said Dr. Stone. "The potential ofthis highly deliverable XIENCE V Stent System represents a welcomeoption for physicians caring for patients with coronary arterydisease."
In November, Guidant announced that SPIRIT II, a 300-patient,randomized clinical trial evaluating XIENCE V outside the U.S., hadcompleted enrollment in only four months. The single-blind,prospective, randomized, non-inferiority study further evaluates theXIENCE V compared to the TAXUS(R) Express 2(TM) Paclitaxel-ElutingCoronary Stent System for the treatment of coronary artery disease.
About XIENCE V
The XIENCE V Everolimus Eluting Coronary Stent System utilizesGuidant's most advanced coronary stent system, the highly deliverablecobalt chromium MULTI-LINK VISION(R), which is available on thepreferred rapid-exchange platform. Everolimus has been shown to reducetissue proliferation in the coronary vessels following stentimplantation. Guidant is ramping up manufacturing and buildinginventory to supply ongoing clinical trials and to support theEuropean launch of XIENCE V beginning in the second quarter of 2006.
Guidant Corporation pioneers lifesaving technology, giving anopportunity for better life today to millions of cardiac and vascularpatients worldwide. The company develops, manufactures and markets abroad array of products and services that enable less invasive carefor some of life's most threatening medical conditions. For moreinformation visit www.guidant.com.
NOTE TO MEDIA: For more information about Guidant, including itsproducts and services, please visit the company's newsroom atwww.guidant.com/newsroom.
This release includes forward-looking statements concerningXIENCE(TM) V. The statements are based on assumptions about manyimportant factors, including completion of the clinical trial,associated regulatory processes and timelines, and other factorsidentified on Exhibit 99 to the company's most recent filing on Form10-Q. Actual results may differ materially. The company does notundertake to update its forward-looking statements.
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