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
You may also be interested in...
Gore Excluder AAA System Approved; Physician Training Plans Under Way
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
Gore Excluder AAA System Approved; Physician Training Plans Under Way
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
Gore Gains Coronary Stent Market Entry With Nirflex Under Medinol Pact
W.L. Gore & Associates will enter the U.S. coronary stent market upon FDA approval of Medinol's Nirflex stent under a Sept. 24 worldwide stent distribution and collaboration agreement