Interventional device vendor Guidant has received investigational device exemption (IDE) conditional approval from the Food and Drug Administration to begin the U.S. portion of its Spirit III clinical trial.
Spirit III is a large-scale clinical trial evaluating the safety and efficacy of Guidant's drug-eluting stent system for the treatment of coronary artery disease, according to the Indianapolis-based firm. The randomized, single-blind trial compares Guidant's Xience V everolimus-eluting coronary stent system, using Guidant's cobalt chromium Multi-Link Vision coronary stent system platform, versus the firm's Taxus Express2 paclitaxel-eluting coronary stent system.
By AuntMinnie.com staff writers
May 5, 2005
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