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Endeavor IV stent data

This article was originally published in The Gray Sheet

Executive Summary

In the lead up to an Oct. 10 PMA panel review, FDA has released detailed results from Medtronic's Endeavor IV trial showing its Endeavor zotarolimus-eluting stent to be as effective as Boston Scientific's Taxus paclitaxel-eluting stent (1"The Gray Sheet" Sept. 17, 2007, p. 4). The 1,548-patient trial met its primary non-inferiority endpoint, showing target vessel failure of 6.8% at nine months, compared to 7.4% for Taxus. But it missed the secondary non-inferiority endpoint of in-segment late loss at eight months (0.36mm versus 0.23mm for Taxus) and nine-month stent thrombosis was higher for Endeavor (0.8% versus 0.1%). Endeavor's worse rates of target lesion revascularization (4.2% versus 2.7%) and target vessel revascularization (5.5% versus 5.0%) were not statistically significant. The Endeavor IV data accompanies an FDA-requested pooled data analysis from all the Endeavor studies in the Circulatory System Devices Panel materials

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