FDAnews Device Daily Bulletin

GUIDANT ENROLLS FIRST PATIENT IN JAPANESE STENT TRIAL

Dec. 15, 2005
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Guidant recently began enrolling patients in the Japanese arm of its Spirit III drug-eluting stent clinical trial as part of a new initiative to promote cooperation between the U.S. and Japan in device approvals.

At issue is a test of Xience V, an everolimus-eluting coronary stent system using Guidant's cobalt chromium Multi-Link Coronary Stent System rapid exchange platform. The 1,380-patient clinical trial includes an 88-patient registry in Japan.

Guidant's SPIRIT III trial is one of the first to participate in Harmonization By Doing (HBD), an initiative to promote the convergence of regulatory requirements, processes and timelines between Japan and the U.S. HBD represents international collaboration between Japan's Ministry of Health, Labor and Welfare / Pharmaceutical Medical Device Agency, the FDA, industry, clinical investigators, investigational sites and academia.

Guidant's participation in piloting SPIRIT III will provide the opportunity to evaluate XIENCE V in both Japan and the U.S. concurrently in the same clinical trial, as opposed to conducting separate sequential trials in each country, the company said.