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Guidant gets OK to expand US DES (drug-eluting stent) trial:

This article was originally published in Clinica

Executive Summary

The FDA has given Guidant the green-light to expand enrolment in the US portion of its SPIRIT III drug-eluting stent (DES) trial to the full cohort of 1,292 patients at up to 80 sites. The study is comparing the firm's everolimus-eluting stent, XIENCE V, with the current market-leading DES, Boston Scientific's paclitaxel-eluting stent, Taxus. Results from SPIRIT III will be used to seek FDA approval for XIENCE V for treating coronary artery disease. Guidant initially received conditional investigational device exemption approval to begin the trial with a limited number of sites in May. Some 117 patients have been enrolled in the study to date. XIENCE V comprises as its stent platform Guidant's cobalt chromium Multi-Link Vision system.

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