Gore atrial septal occluder
This article was originally published in The Gray Sheet
Executive Summary
W.L Gore launches the Gore Helex septal occluder Oct. 3 with a modified catheter delivery system to close atrial septal defects. Same-day 510(k) clearance modifies the original delivery system with which the implanted prosthesis, most often used to treat heart defects in children, was first PMA-approved by FDA in August 2006