Physician-to-Physician Presentation - Gore Medical

IndicationThe GORE HELEX Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous,transcatheter closure of atrial septal defects (ASDs), such as ostium secundum and Patent ForamenOvale.

Product AttributesCompliant DesignCircular ShapeFlat ProfileePTFE Occlusion MembraneCircumferential NitinolSupport Frame

Device ComponentsePTFECentral EyeletNitinol FrameRight Atrial EyeletDelivery Catheter

Locking the DevicePre-LockPost-LockRight Atrial EyeletRetrieval CordMandrelExtended Lock Loop(In Mandrel)Left AtrialMandrel FlareRetrieval CordMandrelRight Atrial EyeletLeft Atrial EyeletRadiopaque TipCenter EyeletRadiopaque TipLock LoopCenter EyeletMandrel is pulled backLock loop forms

Flat Profile and Low Metal Mass

Flexible and CompliantFluoroscopy at one month follow-upin patient with deficient anteriorsuperior rimDevice observed splaying aorta

Inert and BiocompatibleePTFE proven in more than25 million clinical implantsReduced thrombogenicityPorosity engineered for controlledtissue responseAllows formation of functionalintimal liningAfter three months in canine model

Easily RetrievableRetrieval cord maintains connectionbetween device and delivery systemAllows tension-free confirmationof device position after lock release,and easy retrieval if necessary

Hydrophilic CoatingHydrophilic coating facilitatesimmediate wetting of membraneDryWetClear echo visibility of the device

Animal DataIn vivo tissue responsedemonstrating flat profile,conformance to the septum,and non-thrombogenicOccluder material.Left Atrial ViewRight Atrial Side ViewRetrieval after threemonths incanine model

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.

GORE HELEX Septal Occluder SizingThe GORE HELEX Septal Occludercomes in five sizes(15 mm – 35 mm)It is recommended for ASDsand PFOs measuring up to 18 mmWhen choosing the appropriatesize, a 2:1 device diameter todefect diameter ratiois recommended

INDICATIONS FOR USE OUTSIDE THE US: The GORE HELEX Septal Occluder is a permanentlyimplanted prosthesis indicated for the percutaneous, transcatheter closure of atrial septal defects(ASDs), such as ostium secundum and Patent Foramen Ovale. Refer to Instructions for Use atgoremedical.com for a complete description of all contraindications, warnings, precautions andadverse events.Products listed may not be available in all markets.GORE, HELEX, and designs are trademarks of W. L. Gore & Associates.© 2009 W. L. Gore & Associates, Inc. AL0049-EU1 JUNE 2009