波科介入FilterWire中文保护伞

VascularProtectionTrainingAdvancedClinicalTraining波科介入FilterWire中文保护伞第1页TheProductFeaturesandIntendedBenefits波科介入FilterWire中文保护伞第2页3of128FilterWireEZ™

EmbolicProtectionSystemTheFilterWireEZSystemisBSC’ssecondgenerationembolicprotectionfilter.ItincorporatesanumberofdesignchangesfromtheFilterWireEX™System(FirstGenerationSystem)intendedtoimprovetheeffectivenessandeaseofuse.EuropeSeptembercommercializationforSVG,nativecoronary,peripheralandcarotidinterventionDominantmarketshare(PVandCV)despitemanyotherembolicprotectionfiltercompetitorsUSAugustcommercializationforSVGinterventionIncreasedmarketshareandmarketpenetrationDecember510(k)approvedforcarotidindication波科介入FilterWire中文保护伞第3页4of128FilterWireEZ™

SystemComponentsFilterWireEZ5.5mmSystemProtectionWireEZDeliverySheathEZRetrievalSheathAccessories

(peel-awayintroducer,guidewiretorquer,valvedilatortool)FilterWireEZBentTipRetrievalSheath

(availableseparately)波科介入FilterWire中文保护伞第4页5of128FilterWireEZ™System

AccessoriesPeel-awayIntroducerSheathUsedtopreventdamagetothespringtipoftheprotectionwireduringsysteminsertionintoarotatingorfixedhemostasisvalve.GuideWireTorquerIntendedtoenhancetheoperator’sgripontheprotectionwireforsteerabilityduringdeliveryandtoprovideleverageduringfilterdeploymentandcapture.ValveDilatorToolUsedwithafixedhemostasisvalvetominimizedamagetothefilterbaguponremovalthroughthevalve.波科介入FilterWire中文保护伞第5页6of128FilterWireEZ™SystemPEBAXisaregisteredtrademarkofAtofinaCorporationAtraumatic3cm,platinum,springcoiltipwithfloppyflexibilityRadiopaquetoenhancevisualizationShapeabletoenhancesteerability6.0mmPEBAX®NoseconeFlexibletransitionfromthespringtiptothedeliverysheathforexcellentoveralldeliverabilityProvidesaprofiletransitionthatisdesignedtoreducetheriskofdebrisembolizationduringsystemdelivery波科介入FilterWire中文保护伞第6页7of128FilterWireEZ™SystemPolyurethanefiltermembranewith110micronporesDesignedtocapturesdebrisandreducetheriskofembolicrelatedeventsIntendedtopermitcontinuousbloodflowforpatientsafetyandcomfortIntendedtopermitcontinuousbloodflowthatallowscontrastinjectionsforvisualizationduringtheintervention波科介入FilterWire中文保护伞第7页8of1285.5mm4.5mm3.5mmFilterWireEZ™SystemConforming,nitinolfilterloopwithplatinumcoilHighlyvisibletoguidefilterplacementandtoensuregoodvesselwallappositionOnedevicethataccommodatesvesselswithlandingzonediametersrangingfrom3.5mmto5.5mmminimizessizingguessworkandinventoryneedsDesignedtoprovidecontinuouswallappositionaroundthecircumferenceofthevessellumentominimizetheopportunityfordebristocollectontheoutsideofthefilterAutomaticallyadjuststochangesinthevesselaperture波科介入FilterWire中文保护伞第8页9of128FilterWireEZ™SystemFilterloopsuspensionarmallowsthefilterlooptomoveindependentlyfromthewireforgoodvesselwallappositioninbothstraightandcurvedanatomySimplifiesthelandingzonerequirementsbyallowinguseinbothstraightandcurvedvesselsNoneedtotake2angioviewstoassessfilterapposition波科介入FilterWire中文保护伞第9页10of128FilterWireEZ™SystemSpinnertubeunderlyingfilterassemblyAllowsthewiretorotateindependentlyfromthedeliverysheathforexcellentsystemsteerability.032”ODCatheterstopProvidesabarrierdesignedtopreventtherapeuticdevicesfromcollapsingthefilterframeLightlyvisibletocontributetovisualizationfordevicepositioning**Note:A0.013”ODpart5mmproximaltothecatheterstopmayalsobevisiblewithsomeequipment.Thispartkeepsthespinnertubeinplace,butletscathetertipspassover.波科介入FilterWire中文保护伞第10页11of128FilterWireEZ™System0.014”StainlesssteelwirebodywithPTFEcoatingAvailablein190cmand300cmwirelengths190cmwirelengthiscompatiblewithBSC’sAddWire®GuideWireSiliconecoatedondistal15cmofdevice,delivery,andretrievalsheath.Designedtoreducetheamountofforcerequiredtoloadthefilterintothedeliverysheathanddeployinthevessel波科介入FilterWire中文保护伞第11页12of128EZ

DeliverySheath150cmPEBAX®Resinsheathwith100cm,peel-awayexchangelengthThedistalsheathchangescolorfrombluetocleartoserveasawarningthatthenonpeel-awaysectionattheendofthesheathisapproaching1.1mm(0.042”or3.2F)LesioncrossingprofileDistalendhasaPTFEinnerlinerInternalstoploadingfeature–alertstheoperatorthatthefilterisfullysheathed波科介入FilterWire中文保护伞第12页13of128EZRetrievalSheath150cmPEBAX®Resinsheathwitha20cmlongexchangelengthSoftdistaltipDesignedtofacilitatethecapabilitytocrossdeployedstents1.4mm(0.056”or4.3F)lesioncrossingprofileInternalstopcapturefeatureAlertstheoperatorthatthefilterisfullycaptured波科介入FilterWire中文保护伞第13页14of128EZBentTipRetrievalSheath

(soldseparately)150cmPEBAX®Resinsheathwitha20cmexchangelengthBendatdistaltipThebendisdesignedtoaidincrossingstentstrutsthatcancomplicatefilterretrieval1.3mm(0.052”or4.0F)lesioncrossingprofileInternalstopcapturefeatureAlertstheoperatorthatthefilterisfullycaptured波科介入FilterWire中文保护伞第14页FilterWireEZ™

EmbolicProtectionSystemStep-by-StepInstructionsProductDemonstrationPleaserefertothe

FilterWireEZ™EmbolicProtectionSystemDFUforcompleteinstructionsforuse.波科介入FilterWire中文保护伞第15页FilterWireEZ™EmbolicProtectionSystemDFU

availableat/filterwire

FilterWireEZ™System

DFUCard波科介入FilterWire中文保护伞第16页17of128FilterWireEZ™EmbolicProtectionSystem

Pre-ProcedureReviewthepatient’sangiogramanddetermineifthevesselmeetstherequirementsforsafeandeffectiveuseoftheFilterWireEZSystem:Theapexoftheloopcanbedeployedaminimumof3.0cmfromthedistaledgeofthelesion.

Thevesseldiameteratthedesiredlocationofthedeployedfilterloopis3.5mmto5.5mm.(2.25mmto3.5mmforEZSmall)3.5mm–5.5mmvesseldiameter波科介入FilterWire中文保护伞第17页18of128FilterWireEZ™EmbolicProtectionSystem

Pre-Procedure(continued)PriortousingtheFilterWireEZSystem,anticoagulatethepatienttoachieveanACTof≥275secondsforcarotidapplicationsand300secondsforSVGapplications(>200secondsifGPIIb/IIIainhibitorsareused).IntheabsenceofACTmeasurement,administeranappropriateweightbasedbolusofheparin(approximately125units/kg).波科介入FilterWire中文保护伞第18页19of128FilterWireEZ™EmbolicProtectionSystem

Pre-Procedure(continued)RCAgraft-mostcommonlyusedguideisthemultipurpose.Marginalgraft-HockeystickguideisfirstchoicefollowedbyleftAmplatzLADorDiagonalgraft-mostcommonlyusedguidesaretheleftAmplatzandHockeystick.TakenfromMarcoet.al.“StentingofDegeneratedSaphenousVeinGrafts”MayEuroPCRBasedonvesseltake-off,physicianshouldconsiderwhichguidecathetershapewillprovidethebestaccessandsupport.波科介入FilterWire中文保护伞第19页20of128FilterWireEZ™EmbolicProtectionSystem

PREP:DeliverySystem1.Openthepouchusingsterilehandlingprocedureandplacethepackagingcoilsandaccessorykitintothesterilefield.2.Unclipandremovetheyellowhousingthatprotectsthefilter.

Note:Theprotectionwireispre-loadedintothedeliverysheath.

3.Detachthepre-loaded

protectionwirefromtheretainingclip,advancethedeliverysheath,thengraspthe

clearsectionofthesheath

andremove

sheathedwirefromthecoil.FilterWireEZ™SystemProductPackaging波科介入FilterWire中文保护伞第20页21of1284.SheaththeprotectionwireandfilterbyretractingthedeviceintotheEZDeliverySheathwhilethefilterisimmersedinheparinizedsaline.

NOTE:HoldtheDeliverysheathabout1cmproximaltothedarksection.NOTE:Keepthefilterunsheatheduntilimmediatelypriortouse.FilterWireEZ™EmbolicProtectionSystem

PREP:DeliverySystem(continued)3.Attachthewiretorquerontotheproximalendoftheprotectionwire.GuideWireTorquer波科介入FilterWire中文保护伞第21页22of128FilterWireEZ™EmbolicProtectionSystem

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

NOTE:Useofaguidingcatheteroraguidingsheathwitha1.91mm(0.075”)orlargerrotatinghemostasisvalveisrecommendedwhenperformingaprocedurewiththeFilterWireEZSystem.Theuseofasheath/guidecatheterwithafixedhemostasisvalvemaycausethefiltermembranetotearatthehemostasisvalveuponremoval.1.Placethepeel-awayguidewireintroduceroverthetipofthedeliverysystem(thespringtipofthesystemcanbeshapedasneeded).Peel-awayIntroducerSheath波科介入FilterWire中文保护伞第22页23of128FilterWireEZ™EmbolicProtectionSystem

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

NOTE:Considerusingthebuddywiretechniqueifthelesionisdifficulttopass.RetractthebuddywireafterthelesionhasbeencrossedbytheFilterWireEZSystem(Ifothereffortsareunsuccessful,pre-dilatationcanbeused.)波科介入FilterWire中文保护伞第23页24of128FilterWireEZ™EmbolicProtectionSystem

Delivery(continued)5. AdvancetheFilterWireEZSystemacrossthelesionuntiltheapexofthefilterloopcanbedeployedaminimumof3.0cmdistaltothelesion.NOTE:Ifaninterventionaldevicewithatip-to-shoulderlengthofgreaterthan10.0mmistobeused,alongervessellengthmayberequiredtoplacetheFilterWireEZSysteminordertoavoidcontactbetweenthefilter’scatheterstopandthetipoftheinterventionaldevice.波科介入FilterWire中文保护伞第24页25of128Oncetheprotectionwireisinplacepastthelesion,slidethetorquertipuptothehemostaticvalveandtightenfirmly.Deploythefilterbyholdingtheprotectionwirewiththetorquer,thenretractingandcompletelyremovingthedeliverysheath.Besuretokeepthetorquerinplaceasyoupeel-awaythedeliverysheathinastraightmotionuntilthe3cmover-the-wiresectionisreached(seephotobelow).FilterWireEZ™EmbolicProtectionSystem

FilterDeploymentincorrectCORRECTPhotographtakenbyBostonScientificCorporation波科介入FilterWire中文保护伞第25页26of1284. Oncethedeliverysheathiscompletelyremoved,injectcontrastandverifythedeviceisintheproperpositionandthereisadequateflow.

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

FilterDeployment(continued)波科介入FilterWire中文保护伞第26页27of1281.Injectcontrastfrequentlyandalwaysafteranyinterventionorexchange,tovisuallyverifythatbloodflowisnotobstructedandthatfilterloop/vesselappositiontothevesselwallismaintained.

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

Note:Failuretostabilizetheprotectionwirecouldleadtoinadvertentmovementofthefilter,resultinginprotectionwireentanglementand/ordelayintheprocedure.FilterWireEZ™EmbolicProtectionSystem

DuringtheProcedure波科介入FilterWire中文保护伞第27页28of128FilterWireEZ™EmbolicProtectionSystem

FilterCaptureandRetrieval1.RemovetheEZRetrievalSheathfromitspackagingcoilandflushwithheparinizedsaline.2.Advancetheretrievalsheathovertheprotectionwirepastanydeployedstentsuptotheproximalendofthefilterloop.Note:IftheEZRetrievalSheathisnotabletopassthedeployedstent,besurethestentiswellapposedandconsiderpost-dilitation.IftheRetrievalSheathisstillunabletocross,trytheEZBentTipRetrievalSheath(availableseparately).EZBentTipRetrievalSheathPackaging波科介入FilterWire中文保护伞第28页29of128FilterWireEZ™EmbolicProtectionSystem

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

RetrievalSheathMarkerBandAB波科介入FilterWire中文保护伞第29页30of128FilterWireEZ™EmbolicProtectionSystem

FilterCaptureandRetrieval(continued)

NOTE:Ifresistanceisfeltbeforethedistaledgeofthecollapsedfilterloopisalignedwiththemarkerband,itispossiblethatthereisalargeamountofembolicdebrisinthefilter.CarefullyretracttheprotectionwireandEZRetrievalSheathasasystem.Thedistalpartofthefilterbagwillbeoutsideofthesheathduringretrievalinthiscase;however,thefilterloopmustbepulledfullyintothesheath.FullyRetractedFilterLargeDebrisLoadinFilter波科介入FilterWire中文保护伞第30页31of128FilterWireEZ™EmbolicProtectionSystem

FilterCaptureandRetrieval(continued)5.IfanyresistanceismetduringretractionofthesheathedFilterWireEZSystem,slightlyadvancethesheathedFilterWireEZSystemandrotatethesheathbeforecontinuingtoretract.6.Slowlyandcarefullyretracttheentiresystemuntilthetipoftheretrievalsheathisadjacenttothetipoftheguidingcatheterorguidingsheath.7. Ifthereisanyresistance,retracttheguidingcatheterandFilterWireEZSystemtogether.Thisisdoneincasethereisalargeamountofembolicmaterialcapturedinthefilterthatmaynotfitinsidetheguidingcatheter.波科介入FilterWire中文保护伞第31页32of128FilterWireEZ™EmbolicProtectionSystem

FilterCaptureandRetrieval(continued)8.RemovetheFilterWireEZSystemfromthepatient. NOTE:Whenusinga

rotatinghemostasisvalve,ensurethatthehemostasisvalveisfullyopenedpriortoFilterWireEZSystemremoval.

CAUTION:Ifaguidesheathwithafixedhemostasisvalveisused,thevalvedilatortoolisrequiredforFilterWireEZSystemremoval.RemovingtheFilterWireEZSystemthroughafixedhemostasisvalvewithouttheuseofavalvedilatormaycausethefiltermembranetotear.9.Ifafixedhemostasisvalveisused,placethevalvedilator(ifprovidedintheaccessorykit)ontheshaftoftheretrievalsheathandslidethetoolintothevalve.ThenremovetheFilterWireEZSystemfromthepatientthroughthevalvedilatortoolandremovethedilator.波科介入FilterWire中文保护伞第32页33of128StentEntanglementPotentialforadistalembolicprotectionfiltertoentanglewithastentisinherenttointerventionalproceduresusingthesedevices.SAFEPRACTICEFORDISTALPROTECTIONFILTERS:AchievegoodguidecatheterorguidesheathsupportEnsuresufficientlandingzoneKeepthefilterinplaceduringdeploymentMinimizewiremovementduringtheprocedureAchievefullstentapposition波科介入FilterWire中文保护伞第33页34of128FilterWireEZ™EmbolicProtectionSystem

TipsforUseKeySuccessFactorsforUsingtheFilterWireEZSystemKeepACTlevels275secondsforcarotidproceduresand300secondsforSVGprocedures.Ifthereisdifficultycrossingthelesion,tryabuddywireand/or,forcarotidprocedures,havethepatientturntheirheadtotheleftorright.Forcarotidprocedures,placethefilterasdistalaspossiblewhileremainingwithintheextracranialportionoftheICA.Duringdeploymentandexchanges,stabilizethewireandwipeitfrequentlytodecreasefriction.Keepyoureyeonthefilter!Knowwhereitisandknowwhereitissupposedtobe.Verifyflowoften.Slowflow?Finishtheprocedureandremove.Noflow?Removeandreplace.TheFilterWireEZSystemneedsflowtofunction.Donottreatthelesionor“touchup”withoutaFilterWireEZSysteminplace.波科介入FilterWire中文保护伞第34页CompetitionRXACCUNET®(Abbott)Angioguard(Cordis)Emboshield®System(Abbott)Spider(ev3)波科介入FilterWire中文保护伞第35页36of128Competition

FixedWireFilters‘SheathedFixedWire’Devices:FilterWireEZ™System,RXAccunet®,Characteristics

Filterattachedtoa proprietarywireDeliverysheathrequiredPhotobyBostonScientific波科介入FilterWire中文保护伞第36页37of128Competition

WireofChoiceFilters‘WireofChoice’Device:SpiderFX®Device, EmboshieldCharacteristics:Useany.014”wiretogainaccessDeliversheathedfilterandproprietaryguidewireoverthe‘wireofchoice’,thenremove‘wireofchoice’Wirecanmoveslightly(~8mmoflongitudinal“play”)withoutmovingfilterCANNOTremove/replacedeployedfilterwhilemaintainingaccessSpideRX®波科介入FilterWire中文保护伞第37页38of128Competition

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

CharacteristicsOcclusiveprotectionpriortocrossinglesionProxisstopsflowandthenaspiratestoremoveemboliProxis®GuardWire®波科介入FilterWire中文保护伞第38页ImagebyBostonScientificCorp.AbbottVascularDevicesRXACCUNET®EmbolicProtectionSystem波科介入FilterWire中文保护伞第39页40of128Competition

RXACCUNET®SystemDeliveryRetrievalFilterBagDeliverymethod:SheathedwireImagesbyBostonScientificCorp.波科介入FilterWire中文保护伞第40页Competition

RXACCUNET®SystemFilterSizeFullyExpandedReferenceVesselDiameter(MintoMaxRange)MinimumSheathSizeMINIMUMGUIDINGCATHETERSIZE4.5mm3.25mm–4.0mm6F8F5.5mm4.0mm–5.0mm6F8F6.5mm5.0mm–6.0mm6F8F7.5mm6.0mm–7.0mm6F8FTechnicalspecsexcerptedfromRXACCUNETSystemDirectionsforUseandotherliteraturepublishedbyAbbottVascularatasofMarch10,波科介入FilterWire中文保护伞第41页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,波科介入FilterWire中文保护伞第42页43of128ExcellentDeliverabilityGuidewireanddeliverysheathentervesselasoneunitHighlyflexibletonavigatetortuousanatomyLowprofileandsmoothtransitionfromtiptofilterbasket.014”wireistorquedindependentfromfilterbasketAccurateDeploymentRapidexchangeunsheathingforstabilityandsimplicityPeelawaydeliverysheathallowsforcontrolleddeploymentCaptureandControlforOptimalProtectionHighlyflexiblefilterbasketdesignedtoconformtotortuosityDesignedtocapturehighvolumewhileallowingadequatebloodflowConcentricdesignwithguidewirecenteredinfilterFourplatinumradiopaquemarkerssurroundfilterforvisualizationofwallappositionSecureFilterRetrievalChoiceoftworapidexchangerecoverycathetersdesignedspecificallyforthechallengesoffilterrecovery.RXACCUNETRecoveryCatheterShapeabledistaltipsteerscatheterfromstentstrutsduringadvancementFilterbasketsecuredwithallcagestrutopeningsenclosedduringwithdrawalRXACCUNET2RecoveryCatheterLow-profile,flexibletiptoallowfordeflectionawayfromstentstrutsduringadvancementFlexiblecatheter/shaftoptimizedforchallengingguidecatheter/sheathaccessCathetershaftmarkersat95and105cmforreducedflourotimeCompetition

RXACCUNET®SystemInformationononRXACCUNETSystemexcerptedfromliteraturepublishedbyAbbottVascularat.波科介入FilterWire中文保护伞第43页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,波科介入FilterWire中文保护伞第44页ImagebyBostonScientificCorp.AbbottVascularDevicesEmboshield®BareWire®RapidExchangeEmbolicProtectionSystem波科介入FilterWire中文保护伞第45页46of128Competition

Emboshield®SystemDeliverymethod:BareWire®Device/wirefirstCrosslesionwithprovided

BareWireDevice,thenadvanceFilterDeliveryCatheteroverBareWireDevicetodeploymentsite(note:thefiltercanonlybepositionedproximaltothe0.019”stepontheBareWireDevice)DeliveryRetrievalFilterBagImagesbyBostonScientificCorp.InformationexcerptedfromEmboshieldSystemDFU.波科介入FilterWire中文保护伞第46页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,波科介入FilterWire中文保护伞第47页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,.波科介入FilterWire中文保护伞第48页49of128Competition

Emboshield®SystemPerceivedStrengthsPerceivedWeaknessesAbilitytocrosstightlesionsusingarelativelysimplesystem(providedguidewirewith0.019”stop)Lowcaptureefficiencyonabend1Abilitytoretrievethefilterwhileleavingthewireinplace.Significantforceisrequiredtodeliverthedevice2Multiplesizeswithvesselcoverageof2.8to6.2mmdiameterLimitedradiopacityRequirescrossingthelesiontwicepriortoprotection–firstwithBareWireandthenw/deliverycatheterIncreasedproceduraltimeLargelandingzonerequiredImagesbyBostonScientificCorp.波科介入FilterWire中文保护伞第49页50of128InformationonEmboshieldSystemexcerptedfromliteraturepublishedbyAbbottVascularandmadeavailableatasofMarch10,Competition

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

CHOICEFiveDifferentWireSupportLevelsEachavailableintwolengthsofferlesion-specificaccessandsupportTheSupersupportBareWireDeviceispackagedwiththe EmboshieldSystemSAFETYOptimizedFitofRetrievalCathetertoWireSnugfitofcathetertiptowireenhancestrackabilityand reducesthelikelihoodofcatchingonthestent.CompleteFilterEncapsulationforthesecureremovalofdebrisEmboshield

SystemenablescompleteretrievalforthesecureremovalofdebrisCONFIDENCESupportLevelSoftMediumExtraSuperMaximum波科介入FilterWire中文保护伞第50页SpiderFXDevicepictureexcerptedfromliteraturepublishedbyeV3andmadeavailableatasofMarch10,ev3Spi