Coronary Artery Disease

Company gets approval to expand U.S. drug-eluting stent trial

Published in Medical Letter on the CDC and FDA, September 25th, 2005

Guidant Corp. (GDT) 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 1292 patients at up to 80 sites.

SPIRIT III is a large-scale, pivotal clinical trial evaluating XIENCE V, an everolimus- eluting coronary stent system utilizing Guidant's cobalt chromium MULTI-LINK VISION Coronary Stent System platform. This prospective, single-blind trial evaluates the safety and efficacy of XIENCE V compared to the TAXUS Express 2 Paclitaxel Eluting Coronary Stent System for the treatment of coronary artery disease....

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Source: Medical Letter on the CDC and FDA (2005-09-25)

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