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Gore’s Excluder AAA Endoprosthesis Is Approvable With Conditions – Panel

This article was originally published in The Gray Sheet

Executive Summary

The safety profile and anticipated clinical benefits of W.L. Gore & Associates' Excluder bifurcated endoprosthesis justify approval of the device even though the clinical study's primary effectiveness endpoint was not met, FDA's Circulatory System Devices Panel concluded Sept. 9

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