Guidant Begins Enrollment in U.S. Drug Eluting Stent Trial; Large-Scale Pivotal Trial to Evaluate Safety and Efficacy of Next-Ge
22 Juin 2005 - 10:29PM
Business Wire
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(R)
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 & 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(R) 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.
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