FDAnews Device Daily Bulletin

GUIDANT COMPLETES ENROLLMENT IN INTERNATIONAL DRUG ELUTING STENT CLINICAL TRIAL

Nov. 14, 2005
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Guidant recently announced that the company has completed enrollment in its Spirit II drug eluting stent clinical trial. Spirit II is a 300-patient randomized clinical trial evaluating Xience V, an everolimus eluting coronary stent system utilizing Guidant's cobalt chromium rapid-exchange Multi-Link Vision Coronary Stent System platform. This single-blind, prospective, randomized, non-inferiority 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. The primary endpoint of the trial is in-stent late loss at six months.

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