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Guidant suspends Xience V supply, stops enrollment in Spirit 3 trial
By Lisa Kerner
Erie, Pa., March 29 - Guidant Corp. said about 1% of its current Xience V inventory was not manufactured to quality standards and as a result, the company will not release current Xience V inventory, according to a company news release.
The company has also stopped enrolling new patients in the 4.0 mm and the Japan arms of the non-randomized portion of its Spirit 3 clinical trial, designed to evaluate the safety and efficacy of the Xience V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. Guidant said it plans to re-supply units to investigators when new inventory is available.
More than 1,000 patients have already been enrolled in the randomized U.S. portion of the trial.
"Guidant is committed to providing the highest-quality products for the treatment of heart disease," Guidant's president, Vascular Intervention, John Capek said in the release.
"To ensure that the product meets Guidant's quality standards, the company will not utilize existing inventories and will rebuild devices for Spirit 3 and the upcoming European launch. This action will result in a charge of approximately $15 million in the first quarter to write-off existing Xience V inventory and will delay the European launch of Xience V until the third quarter of 2006."
The Food and Drug Administration, the chairman of the Spirit 3 Data Safety Monitoring Board, Boston Scientific and Abbott, have been notified of the temporary suspension.
Located in Indianapolis, Guidant develops, manufactures and markets products and services that enable less-invasive care of medical conditions.
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