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Guidant Begins Enrollment in
European Drug Eluting Stent Study Data From Study Will Support Launch of XIENCE V Coronary Stent System Outside the United States INDIANAPOLIS & BRUSSELS, Belgium -- July 6, 2005 -- Guidant Corporation (NYSE:GDT - News) today announced that the company has begun enrollment in its SPIRIT II drug eluting stent clinical study. SPIRIT II is a 300-patient study evaluating XIENCE™ V, an everolimus eluting coronary stent system utilizing Guidant's cobalt chromium MULTI-LINK VISION® Coronary Stent System platform. This single-blind, randomized controlled study further evaluates the XIENCE V compared to the TAXUS® Express 2™ Paclitaxel Eluting Coronary Stent System for the treatment of coronary artery disease. Results of the SPIRIT II study will provide additional clinical data to support the launch of XIENCE V in several countries outside the United States. "SPIRIT II will provide additional important data about drug eluting stents for the treatment of coronary artery disease, a growing cause of disability around the world," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant. The first patient was enrolled by Gert Richardt, Prof., M.D., of Segeberger Kliniken GmbH, in Bad Segeberg, Germany. "I am enthusiastic about the potential of the XIENCE V everolimus eluting stent system for the treatment of coronary artery disease," said Prof. Richardt. "I look forward to the results from SPIRIT II, which will provide additional data on this important therapy." Guidant recently announced the U.S. initiation of SPIRIT III, a large-scale pivotal clinical trial evaluating XIENCE V. Results of the SPIRIT III trial may be used to obtain FDA approval for XIENCE V for the treatment of coronary artery disease. 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. This release includes forward-looking statements concerning XIENCE™ V. The statements are based on assumptions about many important factors, including satisfactory enrollment and completion of the clinical study, 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. Source: Guidant CorporationContact: |
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