Interventional device firm Guidant said it has decided not to release current inventory of its Xience V everolimus-eluting coronary stent system, as approximately 1% of its current inventory was not manufactured with strict adherence to the company's quality standards.
As a result of the suspension, the Indianapolis-based firm has voluntarily stopped enrolling new patients in the 4.0 mm and Japan arms of the nonrandomized portion of its Spirit III clinical trial. Guidant has already completed enrollment of 1,002 patients in the randomized U.S. portion of the trial, which is designed to evaluate the safety and efficacy of Xience V for the treatment of coronary artery disease.
Guidant said that it will not utilize existing inventories, and will rebuild devices for Spirit III and the system's upcoming European launch. As a result of the delay, the European launch will be postponed until the third quarter of 2006, Guidant said.
By AuntMinnie.com staff writers
March 29, 2006
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