波科介入FilterWire中文保護(hù)傘

VascularProtectionTrainingAdvancedClinicalTraining第1頁(yè)TheProductFeaturesandIntendedBenefits第2頁(yè)3of128FilterWireEZ?

EmbolicProtectionSystemTheFilterWireEZSystemisBSC’ssecondgenerationembolicprotectionfilter.ItincorporatesanumberofdesignchangesfromtheFilterWireEX?System(FirstGenerationSystem)intendedtoimprovetheeffectivenessandeaseofuse.EuropeSeptember2023commercializationforSVG,nativecoronary,peripheralandcarotidinterventionDominantmarketshare(PVandCV)despitemanyotherembolicprotectionfiltercompetitorsUSAugust2023commercializationforSVGinterventionIncreasedmarketshareandmarketpenetrationDecember2023510(k)approvedforcarotidindication第3頁(yè)4of128FilterWireEZ?

SystemComponentsFilterWireEZ5.5mmSystemProtectionWireEZDeliverySheathEZRetrievalSheathAccessories

(peel-awayintroducer,guidewiretorquer,valvedilatortool)FilterWireEZBentTipRetrievalSheath

(availableseparately)第4頁(yè)5of128FilterWireEZ?System

AccessoriesPeel-awayIntroducerSheathUsedtopreventdamagetothespringtipoftheprotectionwireduringsysteminsertionintoarotatingorfixedhemostasisvalve.GuideWireTorquerIntendedtoenhancetheoperator’sgripontheprotectionwireforsteerabilityduringdeliveryandtoprovideleverageduringfilterdeploymentandcapture.ValveDilatorToolUsedwithafixedhemostasisvalvetominimizedamagetothefilterbaguponremovalthroughthevalve.第5頁(yè)6of128FilterWireEZ?SystemPEBAXisaregisteredtrademarkofAtofinaCorporationAtraumatic3cm,platinum,springcoiltipwithfloppyflexibilityRadiopaquetoenhancevisualizationShapeabletoenhancesteerability6.0mmPEBAX?NoseconeFlexibletransitionfromthespringtiptothedeliverysheathforexcellentoveralldeliverabilityProvidesaprofiletransitionthatisdesignedtoreducetheriskofdebrisembolizationduringsystemdelivery第6頁(yè)7of128FilterWireEZ?SystemPolyurethanefiltermembranewith110micronporesDesignedtocapturesdebrisandreducetheriskofembolicrelatedeventsIntendedtopermitcontinuousbloodflowforpatientsafetyandcomfortIntendedtopermitcontinuousbloodflowthatallowscontrastinjectionsforvisualizationduringtheintervention第7頁(yè)8of1285.5mm4.5mm3.5mmFilterWireEZ?SystemConforming,nitinolfilterloopwithplatinumcoilHighlyvisibletoguidefilterplacementandtoensuregoodvesselwallappositionOnedevicethataccommodatesvesselswithlandingzonediametersrangingfrom3.5mmto5.5mmminimizessizingguessworkandinventoryneedsDesignedtoprovidecontinuouswallappositionaroundthecircumferenceofthevessellumentominimizetheopportunityfordebristocollectontheoutsideofthefilterAutomaticallyadjuststochangesinthevesselaperture第8頁(yè)9of128FilterWireEZ?SystemFilterloopsuspensionarmallowsthefilterlooptomoveindependentlyfromthewireforgoodvesselwallappositioninbothstraightandcurvedanatomySimplifiesthelandingzonerequirementsbyallowinguseinbothstraightandcurvedvesselsNoneedtotake2angioviewstoassessfilterapposition第9頁(yè)10of128FilterWireEZ?SystemSpinnertubeunderlyingfilterassemblyAllowsthewiretorotateindependentlyfromthedeliverysheathforexcellentsystemsteerability.032”O(jiān)DCatheterstopProvidesabarrierdesignedtopreventtherapeuticdevicesfromcollapsingthefilterframeLightlyvisibletocontributetovisualizationfordevicepositioning**Note:A0.013”O(jiān)Dpart5mmproximaltothecatheterstopmayalsobevisiblewithsomeequipment.Thispartkeepsthespinnertubeinplace,butletscathetertipspassover.第10頁(yè)11of128FilterWireEZ?System0.014”StainlesssteelwirebodywithPTFEcoatingAvailablein190cmand300cmwirelengths190cmwirelengthiscompatiblewithBSC’sAddWire?GuideWireSiliconecoatedondistal15cmofdevice,delivery,andretrievalsheath.Designedtoreducetheamountofforcerequiredtoloadthefilterintothedeliverysheathanddeployinthevessel第11頁(yè)12of128EZ

DeliverySheath150cmPEBAX?Resinsheathwith100cm,peel-awayexchangelengthThedistalsheathchangescolorfrombluetocleartoserveasawarningthatthenonpeel-awaysectionattheendofthesheathisapproaching1.1mm(0.042”or3.2F)LesioncrossingprofileDistalendhasaPTFEinnerlinerInternalstoploadingfeature–alertstheoperatorthatthefilterisfullysheathed第12頁(yè)13of128EZRetrievalSheath150cmPEBAX?Resinsheathwitha20cmlongexchangelengthSoftdistaltipDesignedtofacilitatethecapabilitytocrossdeployedstents1.4mm(0.056”or4.3F)lesioncrossingprofileInternalstopcapturefeatureAlertstheoperatorthatthefilterisfullycaptured第13頁(yè)14of128EZBentTipRetrievalSheath

(soldseparately)150cmPEBAX?Resinsheathwitha20cmexchangelengthBendatdistaltipThebendisdesignedtoaidincrossingstentstrutsthatcancomplicatefilterretrieval1.3mm(0.052”or4.0F)lesioncrossingprofileInternalstopcapturefeatureAlertstheoperatorthatthefilterisfullycaptured第14頁(yè)FilterWireEZ?

EmbolicProtectionSystemStep-by-StepInstructionsProductDemonstrationPleaserefertothe

FilterWireEZ?EmbolicProtectionSystemDFUforcompleteinstructionsforuse.第15頁(yè)FilterWireEZ?EmbolicProtectionSystemDFU

availableat/filterwire

FilterWireEZ?System

DFUCard第16頁(yè)17of128FilterWireEZ?EmbolicProtectionSystem

Pre-ProcedureReviewthepatient’sangiogramanddetermineifthevesselmeetstherequirementsforsafeandeffectiveuseoftheFilterWireEZSystem:Theapexoftheloopcanbedeployedaminimumof3.0cmfromthedistaledgeofthelesion.

Thevesseldiameteratthedesiredlocationofthedeployedfilterloopis3.5mmto5.5mm.(2.25mmto3.5mmforEZSmall)3.5mm–5.5mmvesseldiameter第17頁(yè)18of128FilterWireEZ?EmbolicProtectionSystem

Pre-Procedure(continued)PriortousingtheFilterWireEZSystem,anticoagulatethepatienttoachieveanACTof≥275secondsforcarotidapplicationsand300secondsforSVGapplications(>200secondsifGPIIb/IIIainhibitorsareused).IntheabsenceofACTmeasurement,administeranappropriateweightbasedbolusofheparin(approximately125units/kg).第18頁(yè)19of128FilterWireEZ?EmbolicProtectionSystem

Pre-Procedure(continued)RCAgraft-mostcommonlyusedguideisthemultipurpose.Marginalgraft-HockeystickguideisfirstchoicefollowedbyleftAmplatzLADorDiagonalgraft-mostcommonlyusedguidesaretheleftAmplatzandHockeystick.TakenfromMarcoet.al.“StentingofDegeneratedSaphenousVeinGrafts”May2023EuroPCRBasedonvesseltake-off,physicianshouldconsiderwhichguidecathetershapewillprovidethebestaccessandsupport.第19頁(yè)20of128FilterWireEZ?EmbolicProtectionSystem

PREP:DeliverySystem1.Openthepouchusingsterilehandlingprocedureandplacethepackagingcoilsandaccessorykitintothesterilefield.2.Unclipandremovetheyellowhousingthatprotectsthefilter.

Note:Theprotectionwireispre-loadedintothedeliverysheath.

3.Detachthepre-loaded

protectionwirefromtheretainingclip,advancethedeliverysheath,thengraspthe

clearsectionofthesheath

andremove

sheathedwirefromthecoil.FilterWireEZ?SystemProductPackaging第20頁(yè)21of1284.SheaththeprotectionwireandfilterbyretractingthedeviceintotheEZDeliverySheathwhilethefilterisimmersedinheparinizedsaline.

NOTE:HoldtheDeliverysheathabout1cmproximaltothedarksection.NOTE:Keepthefilterunsheatheduntilimmediatelypriortouse.FilterWireEZ?EmbolicProtectionSystem

PREP:DeliverySystem(continued)3.Attachthewiretorquerontotheproximalendoftheprotectionwire.GuideWireTorquer第21頁(yè)22of128FilterWireEZ?EmbolicProtectionSystem

Delivery2.InserttheFilterWireEZSystemandpeel-awayintroducerassemblyintoaguidecatheter/sheath.OncetheFilterWireEZSystemisinsertedintotheguidingcatheterorguidingsheath,removethepeel-awayintroducer.

NOTE:Useofaguidingcatheteroraguidingsheathwitha1.91mm(0.075”)orlargerrotatinghemostasisvalveisrecommendedwhenperformingaprocedurewiththeFilterWireEZSystem.Theuseofasheath/guidecatheterwithafixedhemostasisvalvemaycausethefiltermembranetotearatthehemostasisvalveuponremoval.1.Placethepeel-awayguidewireintroduceroverthetipofthedeliverysystem(thespringtipofthesystemcanbeshapedasneeded).Peel-awayIntroducerSheath第22頁(yè)23of128FilterWireEZ?EmbolicProtectionSystem

Delivery(continued)3.ToadvancetheFilterWireEZSystemthroughtheguidingcatheterorguidingsheath,useaone-handedtechniqueadvancingboththedeliverysheathandprotectionwiretogether;thiswillpreventaccidentaldeploymentofthefilter.4.TosteertheFilterWireEZSystemtothetargetlandingzone,useatwo-handedtechnique,torquingtheprotectionwirewithonehandandadvancingthedeliverysheathwiththeotherhand.NOTE:Forcarotidinterventions,havingthepatientturntheirheadtotheleftorrightwillchangetheorientationofthevesselandmayfacilitatedevicepassage.

NOTE:Considerusingthebuddywiretechniqueifthelesionisdifficulttopass.RetractthebuddywireafterthelesionhasbeencrossedbytheFilterWireEZSystem(Ifothereffortsareunsuccessful,pre-dilatationcanbeused.)第23頁(yè)24of128FilterWireEZ?EmbolicProtectionSystem

Delivery(continued)5. AdvancetheFilterWireEZSystemacrossthelesionuntiltheapexofthefilterloopcanbedeployedaminimumof3.0cmdistaltothelesion.NOTE:Ifaninterventionaldevicewithatip-to-shoulderlengthofgreaterthan10.0mmistobeused,alongervessellengthmayberequiredtoplacetheFilterWireEZSysteminordertoavoidcontactbetweenthefilter’scatheterstopandthetipoftheinterventionaldevice.第24頁(yè)25of128Oncetheprotectionwireisinplacepastthelesion,slidethetorquertipuptothehemostaticvalveandtightenfirmly.Deploythefilterbyholdingtheprotectionwirewiththetorquer,thenretractingandcompletelyremovingthedeliverysheath.Besuretokeepthetorquerinplaceasyoupeel-awaythedeliverysheathinastraightmotionuntilthe3cmover-the-wiresectionisreached(seephotobelow).FilterWireEZ?EmbolicProtectionSystem

FilterDeploymentincorrectCORRECTPhotographtakenbyBostonScientificCorporation第25頁(yè)26of1284. Oncethedeliverysheathiscompletelyremoved,injectcontrastandverifythedeviceisintheproperpositionandthereisadequateflow.

NOTE:Ifrepositioningisrequired,theEZRetrievalSheathshouldbeused.Retracttheprotectionwireandfilterloopintothesheath,repositionthefilterandredeploy.5. Usetheprotectionwirelikeatraditionalguidewiretotrackcathetersandstentdeliverysystemstothetargettreatmentarea.FilterWireEZ?EmbolicProtectionSystem

FilterDeployment(continued)第26頁(yè)27of1281.Injectcontrastfrequentlyandalwaysafteranyinterventionorexchange,tovisuallyverifythatbloodflowisnotobstructedandthatfilterloop/vesselappositiontothevesselwallismaintained.

CAUTION:Ifafilterbecomesoccludedduringtheprocedure,removeitanddeployasecondfilteriffurtherinterventionisrequired.2.Completetheproceduremakingsuretheprotectionwireremainsintheproperpositiondistaltothelesion(monitorfluoroscopy).

Note:Failuretostabilizetheprotectionwirecouldleadtoinadvertentmovementofthefilter,resultinginprotectionwireentanglementand/ordelayintheprocedure.FilterWireEZ?EmbolicProtectionSystem

DuringtheProcedure第27頁(yè)28of128FilterWireEZ?EmbolicProtectionSystem

FilterCaptureandRetrieval1.RemovetheEZRetrievalSheathfromitspackagingcoilandflushwithheparinizedsaline.2.Advancetheretrievalsheathovertheprotectionwirepastanydeployedstentsuptotheproximalendofthefilterloop.Note:IftheEZRetrievalSheathisnotabletopassthedeployedstent,besurethestentiswellapposedandconsiderpost-dilitation.IftheRetrievalSheathisstillunabletocross,trytheEZBentTipRetrievalSheath(availableseparately).EZBentTipRetrievalSheathPackaging第28頁(yè)29of128FilterWireEZ?EmbolicProtectionSystem

FilterCaptureandRetrieval(continued)3.Gentlyandslowlyretracttheprotectionwireandfilterloopbackintotheretrievalsheathuntilresistanceisfelt.4.Observetheretrievalprocedureunderfluoroscopicimaging.Note:Thedistaledgeofthecollapsedfilterloopshouldalignwith(seefigureB),orbeproximalto(figureA),theretrievalsheathmarkerband.

RetrievalSheathMarkerBandAB第29頁(yè)30of128FilterWireEZ?EmbolicProtectionSystem

FilterCaptureandRetrieval(continued)

NOTE:Ifresistanceisfeltbeforethedistaledgeofthecollapsedfilterloopisalignedwiththemarkerband,itispossiblethatthereisalargeamountofembolicdebrisinthefilter.CarefullyretracttheprotectionwireandEZRetrievalSheathasasystem.Thedistalpartofthefilterbagwillbeoutsideofthesheathduringretrievalinthiscase;however,thefilterloopmustbepulledfullyintothesheath.FullyRetractedFilterLargeDebrisLoadinFilter第30頁(yè)31of128FilterWireEZ?EmbolicProtectionSystem

FilterCaptureandRetrieval(continued)5.IfanyresistanceismetduringretractionofthesheathedFilterWireEZSystem,slightlyadvancethesheathedFilterWireEZSystemandrotatethesheathbeforecontinuingtoretract.6.Slowlyandcarefullyretracttheentiresystemuntilthetipoftheretrievalsheathisadjacenttothetipoftheguidingcatheterorguidingsheath.7. Ifthereisanyresistance,retracttheguidingcatheterandFilterWireEZSystemtogether.Thisisdoneincasethereisalargeamountofembolicmaterialcapturedinthefilterthatmaynotfitinsidetheguidingcatheter.第31頁(yè)32of128FilterWireEZ?EmbolicProtectionSystem

FilterCaptureandRetrieval(continued)8.RemovetheFilterWireEZSystemfromthepatient. NOTE:Whenusinga

rotatinghemostasisvalve,ensurethatthehemostasisvalveisfullyopenedpriortoFilterWireEZSystemremoval.

CAUTION:Ifaguidesheathwithafixedhemostasisvalveisused,thevalvedilatortoolisrequiredforFilterWireEZSystemremoval.RemovingtheFilterWireEZSystemthroughafixedhemostasisvalvewithouttheuseofavalvedilatormaycausethefiltermembranetotear.9.Ifafixedhemostasisvalveisused,placethevalvedilator(ifprovidedintheaccessorykit)ontheshaftoftheretrievalsheathandslidethetoolintothevalve.ThenremovetheFilterWireEZSystemfromthepatientthroughthevalvedilatortoolandremovethedilator.第32頁(yè)33of128StentEntanglementPotentialforadistalembolicprotectionfiltertoentanglewithastentisinherenttointerventionalproceduresusingthesedevices.SAFEPRACTICEFORDISTALPROTECTIONFILTERS:AchievegoodguidecatheterorguidesheathsupportEnsuresufficientlandingzoneKeepthefilterinplaceduringdeploymentMinimizewiremovementduringtheprocedureAchievefullstentapposition第33頁(yè)34of128FilterWireEZ?EmbolicProtectionSystem

TipsforUseKeySuccessFactorsforUsingtheFilterWireEZSystemKeepACTlevels275secondsforcarotidproceduresand300secondsforSVGprocedures.Ifthereisdifficultycrossingthelesion,tryabuddywireand/or,forcarotidprocedures,havethepatientturntheirheadtotheleftorright.Forcarotidprocedures,placethefilterasdistalaspossiblewhileremainingwithintheextracranialportionoftheICA.Duringdeploymentandexchanges,stabilizethewireandwipeitfrequentlytodecreasefriction.Keepyoureyeonthefilter!Knowwhereitisandknowwhereitissupposedtobe.Verifyflowoften.Slowflow?Finishtheprocedureandremove.Noflow?Removeandreplace.TheFilterWireEZSystemneedsflowtofunction.Donottreatthelesionor“touchup”withoutaFilterWireEZSysteminplace.第34頁(yè)CompetitionRXACCUNET?(Abbott)Angioguard(Cordis)Emboshield?System(Abbott)Spider(ev3)第35頁(yè)36of128Competition

FixedWireFilters‘SheathedFixedWire’Devices:FilterWireEZ?System,RXAccunet?,Characteristics

Filterattachedtoa proprietarywireDeliverysheathrequiredPhotobyBostonScientific第36頁(yè)37of128Competition

WireofChoiceFilters‘WireofChoice’Device:SpiderFX?Device, EmboshieldCharacteristics:Useany.014”wiretogainaccessDeliversheathedfilterandproprietaryguidewireoverthe‘wireofchoice’,thenremove‘wireofchoice’Wirecanmoveslightly(~8mmoflongitudinal“play”)withoutmovingfilterCANNOTremove/replacedeployedfilterwhilemaintainingaccessSpideRX?第37頁(yè)38of128Competition

OcclusiveDevicesDistalOcclusionDevice:MedtronicGuardWire?SystemCharacteristics:ProprietarywirewithballoonattachedLowcrossingprofileBallooninflateddistaltolesionShortlandingzoneAspiratetoremoveemboliProximalOcclusionDevices:St.JudeProxis?System

CharacteristicsOcclusiveprotectionpriortocrossinglesionProxisstopsflowandthenaspiratestoremoveemboliProxis?GuardWire?第38頁(yè)ImagebyBostonScientificCorp.AbbottVascularDevicesRXACCUNET?EmbolicProtectionSystem第39頁(yè)40of128Competition

RXACCUNET?SystemDeliveryRetrievalFilterBagDeliverymethod:SheathedwireImagesbyBostonScientificCorp.第40頁(yè)Competition

RXACCUNET?SystemFilterSizeFullyExpandedReferenceVesselDiameter(MintoMaxRange)MinimumSheathSizeMINIMUMGUIDINGCATHETERSIZE4.5mm3.25mm–4.0mm6F8F5.5mm4.0mm–5.0mm6F8F6.5mm5.0mm–6.0mm6F8F7.5mm6.0mm–7.0mm6F8FTechnicalspecsexcerptedfromRXACCUNETSystemDirectionsforUseandotherliteraturepublishedbyAbbottVascularatasofMarch10,2023第41頁(yè)42of128Competition

RXACCUNET?SystemFilterWireEZSystemRXACCUNETSystemDeliveryMethodSheathedwireSheathedwireCrossingProfile3.2F3.5&3.7FDistalTip3.0cm3.0cmVesselDiameterCoverage3.5mm–5.5mm3.25mm–7.0mm(4sizes–4.5,5.5,6.5,7.5)PoreSize110micronRangesupto150micronDeviceWireCharacteristicsModeratesupportExtrasupportLandingZone>3.0cm>4.0cmAppositionCheck1view2viewsRetrievalSheathProfile4.3F5.5FWireLengths190cm,300cm190cm,300cmGuideCatheterReq.6F(minID0.066”)8F(minID0.085”)IndicationsCarotid,SVGCarotidInformationexcerptedfromFilterWireEZSystemandRXACCUNETSystemDirectionsforUseandotherliteraturepublishedbyAbbottVascularatasofMarch10,2023第42頁(yè)43of128ExcellentDeliverabilityGuidewireanddeliverysheathentervesselasoneunitHighlyflexibletonavigatetortuousanatomyLowprofileandsmoothtransitionfromtiptofilterbasket.014”wireistorquedindependentfromfilterbasketAccurateDeploymentRapidexchangeunsheathingforstabilityandsimplicityPeelawaydeliverysheathallowsforcontrolleddeploymentCaptureandControlforOptimalProtectionHighlyflexiblefilterbasketdesignedtoconformtotortuosityDesignedtocapturehighvolumewhileallowingadequatebloodflowConcentricdesignwithguidewirecenteredinfilterFourplatinumradiopaquemarkerssurroundfilterforvisualizationofwallappositionSecureFilterRetrievalChoiceoftworapidexchangerecoverycathetersdesignedspecificallyforthechallengesoffilterrecovery.RXACCUNETRecoveryCatheterShapeabledistaltipsteerscatheterfromstentstrutsduringadvancementFilterbasketsecuredwithallcagestrutopeningsenclosedduringwithdrawalRXACCUNET2RecoveryCatheterLow-profile,flexibletiptoallowfordeflectionawayfromstentstrutsduringadvancementFlexiblecatheter/shaftoptimizedforchallengingguidecatheter/sheathaccessCathetershaftmarkersat95and105cmforreducedflourotimeCompetition

RXACCUNET?SystemInformationononRXACCUNETSystemexcerptedfromliteraturepublishedbyAbbottVascularat.第43頁(yè)44of128ACCUrateCaptureandControlTheRXACCUNETSystemisdesignedtoprovideexcellentcapturecapabilitiesandeasyfiltercontrolwhenperformingcarotidstentinginterventions.TheRXACCUNETSystemisa.014”guidewirebasedfiltersystemthatutilizesrapidexchangetechnologysothatthephysiciancaneasilycontrolthefilterduringcathetermanipulations.Itisavailableinboth190cmand300cmlengthswiththeproximalendofthe190cmdevicecoinedtoallowforattachmenttoa“DOC”wireextension.Thesystemis6Fsheath/8Fguidecathetercompatibleandhasfiltersavailablein4.5,5.5,6.5,and7.5mmbasketdiametersthatarerecommendedforuseinarteriesrangingfrom3.25mmto7.0mm.TheRXACCUNETSystem’sflexiblecagedesignassistsinmaintainingexcellentwallappositioninpulsedflowenvironmentsandchallenginganatomies.TheRXACCUNETSystem’speelawaydeliverysheathallowsforsimpledeploymentwithrapidexchangeunsheathingforstabilityandeaseofuse.Additionally,the.014”wirecanbetorquedindependentlyfromthefilterbasketinordertohelpmanagethenavigationoftortuousanatomy.RecoveryisperformedwithachoiceoftwodedicatedRXrecoverycatheters.

TheoriginalRXACCUNETRecoveryCatheterhasashapeabledistaltipdesignedtooffersteeringcontrolduringadvancement.TheRXACCUNET2RecoveryCatheterislowerprofileandmoreflexibleandwasdesignedtoaccessmoretortuousanatomieswithoutcatchingonstentstruts.Competition

RXACCUNET?System

-PositioningInformationonRXACCUNETSystemexcerptedfromliteraturepublishedbyAbbottVascularandmadeavailableatasofMarch10,2023第44頁(yè)ImagebyBostonScientificCorp.AbbottVascularDevicesEmboshield?BareWire?RapidExchangeEmbolicProtectionSystem第45頁(yè)46of128Competition

Emboshield?SystemDeliverymethod:BareWire?Device/wirefirstCrosslesionwithprovided

BareWireDevice,thenadvanceFilterDeliveryCatheteroverBareWireDevicetodeploymentsite(note:thefiltercanonlybepositionedproximaltothe0.019”stepontheBareWireDevice)DeliveryRetrievalFilterBagImagesbyBostonScientificCorp.InformationexcerptedfromEmboshieldSystemDFU.第46頁(yè)Competition

Emboshield?SystemFilterDiameterVesselSizeRangeCrossingProfile3.0mm2.8-<3.5mm3.7F4.0mm3.5-<4.2mm3.7F5.0mm4.2-<5.2mm3.9F6.0mm5.2–6.2mm3.9FSupportLevelLength(cm)Soft190,315Medium190,315Extra190,315Super190,315Maximum190,315Emboshield?SystemBareWireTechnicalspecsexcerptedfromEmboshieldSystemDirectionsforUseandotherliteraturepublishedbyAbbottVascularandmadeavailableatasofMarch10,2023第47頁(yè)48of128Competition

Emboshield?SystemFilterWireEZSystemEmboshieldSystemDeliveryMethodSheathedfilterwireBareWire?Device/wirefirstCrossingProfile3.2F3.7&3.9FDistalTip3.0cm3.0cmVesselDiameterCoverage3.5mm–5.5mm2.8–6.2mm(4sizes–3,4,5,6)PoreSize110micron140micronDeviceWireCharacteristicsModeratesupport5supportlevels(soft,medium,extra,super,maximum)LandingZone>3.0cm>3.6–4.3cmAppositionCheck1view2viewsRetrievalSheathProfile4.3F5.4FWireLengths190cm,300cm190cm,315cmGuideCatheterReq.6F(minID0.066”)7FIndicationsCarotid,SVGCarotidInformationexcerptedfromFilterWireEZSystemandEmboshieldSystemDirectionsforUseandotherliteraturepublishedbyAbbottVascularandavailableatAsofMarch10,2023.第48頁(yè)49of128Competition

Emboshield?SystemPerceivedStrengthsPerceivedWeaknessesAbilitytocrosstightlesionsusingarelativelysimplesystem(providedguidewirewith0.019”stop)Lowcaptureefficiencyonabend1Abilitytoretrievethefilterwhileleavingthewireinplace.Significantforceisrequiredtodeliverthedevice2Multiplesizeswithvesselcoverageof2.8to6.2mmdiameterLimitedradiopacityRequirescrossingthelesiontwicepriortoprotection–firstwithBareWireandthenw/deliverycatheterIncreasedproceduraltimeLargelandingzonerequiredImagesbyBostonScientificCorp.第49頁(yè)50of128InformationonEmboshieldSystemexcerptedfromliteraturepublishedbyAbbottVascularandmadeavailableatasofMarch10,2023Competition

Emboshield?System-PositioningDesignedforChoice,Safety,ConfidenceWiththeBareWire?Device,thewirecrossesthelesionfirst,independentofthefilteranddeliverycatheter.Allotheractions,includingfilterplacementandretrieval,balloondilatations,andstentplacementthenoccuroverthewire.

CHOICEFiveDifferentWireSupportLevelsEachavailableintwolengthsofferlesion-specificaccessandsupportTheSupersupportBareWireDeviceispackagedwiththe EmboshieldSystemSAFETYOptimizedFitofRetrievalCathetertoWireSnugfitofcathetertiptowireenhancestrackabilityand reducesthelikelihoodofcatchingonthestent.CompleteFilterEncapsulationforthesecureremovalofdebrisEmboshield

SystemenablescompleteretrievalforthesecureremovalofdebrisCONFIDENCESupportLevelSoftMediumExtraSuperMaximum第50頁(yè)SpiderFXDevicepictureexcerptedfromliteraturepublishedbyeV3andmadeavailableatasofMarch10,2023ev3SpiderFX?

EmbolicProtectionDevice第51頁(yè)52of128FilterBag:

Notethenitinolfiltermeshporesizevariesdistaltoproximal.Guidewire:

Notethedeliverysheathdoesnothavea“nosecone”thustheleadingedgeisbluntvs.tapered.Delivery:

Notethefiltersitsjustbehindtherapidexchangeportduringdeliveryoverthepreviouslyplacedguidewire.Thatwireisremovedoncethefiltersystemisdeliveredpastthelesion.BluntedgeofdeliverysheathFilterCompetition

SpideRX?DeviceDeliverymethod:Physicianpreferred.014”or.018”guidewireSystemisprovidedinasinglepackaginghoop,withCaptureWire/Filterpre-loadedintheDeliveryEndoftheSpideRXCatheterRetrievalImagesbyBostonScientificCorp.第52頁(yè)Competition

SpiderFX?DeviceFilterSize(mm)VesselSizeRange(mm)WireLength(cm)CrossingProfile(Fr)GuideCatheter(minID)3.03.0190/3203.26F(0.066”)4.03.1-4.0190/3203.26F(0.066”)