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Guidant Receives Approval to Begin
U.S. Drug Eluting Stent Trial INDIANAPOLIS, May 5, 2005 -- Guidant Corporation (NYSE:GDT - News) today announced that it has received Investigational Device Exemption (IDE) conditional approval from the U.S. Food and Drug Administration (FDA) to begin the U.S. portion of its SPIRIT III clinical trial. SPIRIT III is a large-scale pivotal clinical trial evaluating the safety and efficacy of Guidant's drug eluting stent system for the treatment of coronary artery disease. This prospective, randomized, single-blind trial compares XIENCE™ V, an everolimus eluting coronary stent system utilizing Guidant's cobalt chromium MULTI-LINK VISION® Coronary Stent System platform, versus the TAXUS® Express 2™ Paclitaxel Eluting Coronary Stent System. Results of the SPIRIT III trial may be used to obtain FDA approval for XIENCE™ V for the treatment of coronary artery disease. Guidant expects to begin its SPIRIT II and III clinical trials in the near future. "Guidant is pleased with this FDA conditional approval as it will allow the company to initiate the pivotal trial to evaluate the safety and efficacy of XIENCE™ V," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant. "We are excited to advance the science of drug eluting stents by partnering with SPIRIT III investigators to generate new clinical data utilizing our MULTI-LINK VISION®-based platform." 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™ 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-K. Actual results may differ materially. The company does not undertake to update its forward-looking statements. Source: Guidant CorporationContact: |
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