Guidant Receives FDA Approval to Expand U.S. Drug Eluting Stent Trial; Approval Sufficient for Completion of Pivotal Trial
Posted on: Wednesday, 24 August 2005, 18:00 CDT
Guidant Corporation (NYSE:GDT) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to expand enrollment in the U.S. portion of its SPIRIT III drug eluting stent clinical trial to the full cohort of 1,292 patients at up to 80 sites.
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, 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 will be used to seek FDA approval for XIENCE V for the treatment of coronary artery disease.
The company initially received conditional investigational device exemption approval to begin the trial with a limited number of sites in May. The first patient was enrolled in the study in June.
"SPIRIT III is progressing well, with 117 patients enrolled to date," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant. "New clinical data from this study will serve to broaden our knowledge of the science of drug eluting stents. In the meantime, we look forward to presenting new data in the fourth quarter regarding the one-year follow-up from SPIRIT FIRST."
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.
Source: Business Wire
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