Gore Excluder AAA System Approved; Physician Training Plans Under Way
This article was originally published in The Gray Sheet
Executive Summary
W.L. Gore & Associates' Excluder bifurcated endoprosthesis is the third minimally invasive device for repair of abdominal aortic aneurysms to reach the U.S. market
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Gore’s Excluder AAA Endoprosthesis Is Approvable With Conditions – Panel
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
Circulatory Panel’s September Agenda Includes AAA Device Review
W.L. Gore hopes to receive premarket approval for its Excluder abdominal aortic aneurysm repair system by year-end