Physician-to-Physician Presentation - Gore Medical

US Clinical Trial Data SummaryFeasibility Pivotal * Continued AccessSubjects Enrolled 63 143 196Median Age (years) 11 (0.5-66) 7 (1-72) 5.4 (0.8 – 58)Successful Implant86.4% of attemptedimplants (51 / 59)88.1% of attemptedimplants (119 / 135)85.6% of attemptedimplants (137 / 160)Adverse Events 3.9% 5.9% 2.2%Clnically Successful94.6% 98.1% 99.1%OcclusionComposite Clinical Success 89.5% 91.9% 96.6%*Two arm study comparing surgical closure to device closureClinically Successful Occlusion: No residual leak or insignificant residual leakComposite Clinical Success: Clinically successful occlusion AND no major adverse eventThree US clinical studies were conducted to evaluate the GORE HELEX Septal Occluder. These studies were performedwith the original delivery system. The product described here is the same Occluder with a modified delivery system.Please note that the modified delivery system was not evaluated under the original US clinical study.