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This article was originally published in The Gray Sheet

Executive Summary

Firm announces Oct. 6 it has launched its MultiLink Vision RX coronary stent system in Japan. Guidant's cobalt chromium stent technology will be the platform for its XIENCE V everolimus-eluting system, which is being compared with Boston Scientific's Taxus Express 2 paclitaxel-eluting stent in the SPIRIT II and III trials (1"The Gray Sheet" Sept. 26, 2005, In Brief)...

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Guidant announces Dec. 13 the launch of an 88-patient registry in Japan as part of the SPIRIT III trial of its Xience V everolimus-eluting stent. SPIRIT III is part of the Harmonization By Doing initiative to promote regulatory convergence between the U.S. and Japan, which allows Guidant to conduct one trial for both countries. Guidant hopes it will lead to earlier introduction of the stent in Japan. The company also announces it has passed the halfway enrollment mark in the SPIRIT III U.S. arm, a 1,002-patient, prospective, randomized, single-blind trial comparing Xience V to Boston Scientific's Taxus Express 2 paclitaxel-eluting stent (1"The Gray Sheet" Oct. 10, 2005, In Brief)...

Guidant’s SPIRIT

Over 300 patients are enrolled in the SPIRIT II and SPIRIT III European drug-eluting stent clinical trials, triggering a $60 mil. milestone payment to drug-supplier Novartis, Guidant announces Sept. 21. The trial compares Guidant's Xience V everolimus-eluting stent to Boston Scientific's Taxus paclitaxel-eluting stent. In June, FDA approved an expansion of the SPIRIT III trial to include 1,292 patients at up to 80 sites (1"The Gray Sheet" Aug. 29, 2005, In Brief). The notified body that will review Xience for CE Mark completed its inspection of the firm's Temecula, Calif. facility...

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