Guidant completes enrollment in U.S. portion of drug eluting stent pivotal trial

By Lisa Kerner

Erie, Pa., March 15 - Guidant Corp. said it has completed enrollment of 1,002 patients in the randomized U.S. portion of its Spirit III drug eluting stent pivotal clinical trial.

The randomized cohort will support Guidant's premarket approval submission to the Food and Drug Administration for its Xience V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease, according to a company news release.

The trial will evaluate the safety and efficacy of Guidant's Xience stent compared to the Taxus Express 2 Paclitaxel-Eluting Coronary Stent System for the treatment of coronary artery disease.

"Based on the positive results of Spirit First, Guidant's olimus-based Xience V Everolimus Eluting Coronary Stent System appears to hold great promise as a next-generation therapy for treating coronary artery disease," said Dr. Campbell Rogers, director of cardiac catheterization at Brigham and Women's Hospital and co-principal investigator of the Spirit III study, in the release.

"We look forward to analyzing these data and sharing results of the trial early next year. We also look forward to continuing to examine how the Xience stent performs in diverse patient and lesion subsets in upcoming clinical studies."

Located in Indianapolis, Guidant develops, manufactures and markets products and services that enable less invasive care for some of life's most threatening medical conditions.

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