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www.fdanews.com/articles/82375-guidant-completes-enrollment-in-international-drug-eluting-stent-clinical-trial

GUIDANT COMPLETES ENROLLMENT IN INTERNATIONAL DRUG ELUTING STENT CLINICAL TRIAL

November 11, 2005

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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