Indianapolis, IN - Guidant Corp has voluntarily stopped enrolling patients in several arms of the nonrandomized portion of its SPIRIT III clinical trial, because one out of every 100 Xience V stents may have been manufactured in substandard conditions, the company announced yesterday.

"To maintain the highest level of quality assurance, Guidant has decided not to release current XIENCE V inventory," a company press release stated.

The Xience V everolimus-eluting stent received CE Mark approval in January 2006, but Guidant now plans to delay its European launch until the autumn of 2006. Earlier this month, the company announced that it has completed enrollment of 1002 patients in the randomized US portion of the SPIRIT III trial, comparing the Xience V with the Taxus paclitaxel-eluting stent. Four nonrandomized arms of the trial, taking place in the US and Japan, also form part of the SPIRIT III program, and it is parts of these arms that will be temporarily halted. The company says it intends to restock investigators' supplies and relaunch the trial as soon as possible.

Guidant's decision will cost the company $15 million for the inventory write-off but is not expected to have any bearing on the acquisition agreement currently being finalized with Boston Scientific and Abbott.