Physician-to-Physician Presentation - Gore Medical

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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.
US Clinical Trial Key LearningsGORE HELEX Septal Occluder is safe and effective for the closure of ASDsNo instances of perforation of cardiac structuresNo instances of thrombus on the deviceOptimal results when 2:1 device diameter to defect diameter ratio is used toclose defects up to 18 mmClinical Trial DataDevice to Defect RatioAccess< 1.61.6 – 2.02.0 or greaterClinical Closure 92.6% 96.3% 100.0%Embolization Rate 3.0% 4.2% 0.0%Composite Success 80.0% 90.0% 95.0%*Information comes from Latson, et al., Analysis of factors related to successful transcatheter closure of secundum atrial septal defects usingthe HELEX septal occluder. American Heart Journal 2006;151:1129.e7-1129.e11.
Page 2 and 3: IndicationThe GORE HELEX Septal Occ
Page 4: Device ComponentsePTFECentral Eyele
Page 8 and 9: Flat Profile and Low Metal Mass
Page 10 and 11: Inert and BiocompatibleePTFE proven
Page 12 and 13: Hydrophilic CoatingHydrophilic coat
Page 16 and 17: GORE HELEX Septal Occluder SizingTh

Physician-to-Physician Presentation - Gore Medical

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