Guidant SPIRIT in Japan
This article was originally published in The Gray Sheet
Executive Summary
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)...