NMT STARFlex Single-Arm Study Insufficient For Approval, Panel Concludes
This article was originally published in The Gray Sheet
Executive Summary
NMT Medical must conduct a randomized controlled trial of the STARFlex septal occlusion system to demonstrate that the device is superior to medical therapy in preventing strokes, FDA's Circulatory System Devices Panel concluded at its Sept. 10 meeting in Gaithersburg, Maryland