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1、Confidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.01of128波科介入波科介入FilterWire中文保中文保护伞护伞Confidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.02of128The ProductFeaturesandIntendedBenefitsConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.04of128FilterWireEZ
2、SystemComponentsFilterWire EZ 5.5mm SystemProtectionWireEZDeliverySheathEZRetrievalSheathAccessories(peel-awayintroducer,guidewiretorquer,valvedilatortool)FilterWire EZ Bent Tip Retrieval Sheath(availableseparately)Confidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.05of128FilterWireE
3、ZSystemAccessoriesPeel-away Introducer SheathUsedtopreventdamagetothespringtipoftheprotectionwireduringsysteminsertionintoarotatingorfixedhemostasisvalve.Guide Wire TorquerIntendedtoenhancetheoperatorsgripontheprotectionwireforsteerabilityduringdeliveryandtoprovideleverageduringfilterdeploymentandca
4、pture.Valve Dilator ToolUsedwithafixedhemostasisvalvetominimizedamagetothefilterbaguponremovalthroughthevalve.Confidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.06of128FilterWireEZSystemPEBAXisaregisteredtrademarkofAtofinaCorporationAtraumatic3cm,platinum,springcoiltipwithfloppyflexi
5、bilityRadiopaquetoenhancevisualizationShapeabletoenhancesteerability6.0mmPEBAXNoseconeFlexibletransitionfromthespringtiptothedeliverysheathforexcellentoveralldeliverabilityProvidesaprofiletransitionthatisdesignedtoreducetheriskofdebrisembolizationduringsystemdeliveryConfidential-ForInternalUseOnly-D
6、oNotCopyorDistribute.USCV5164.112.07of128FilterWireEZSystemPolyurethanefiltermembranewith110micronporesDesignedtocapturesdebrisandreducetheriskofembolicrelatedeventsIntendedtopermitcontinuousbloodflowforpatientsafetyandcomfortIntendedtopermitcontinuousbloodflowthatallowscontrastinjectionsforvisualiz
7、ationduringtheinterventionConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.08of1285.5 mm4.5 mm3.5 mmFilterWireEZSystemConforming,nitinolfilterloopwithplatinumcoilHighlyvisibletoguidefilterplacementandtoensuregoodvesselwallappositionOnedevicethataccommodatesvesselswithlandingzonedia
8、metersrangingfrom3.5mmto5.5mmminimizessizingguessworkandinventoryneedsDesignedtoprovidecontinuouswallappositionaroundthecircumferenceofthevessellumentominimizetheopportunityfordebristocollectontheoutsideofthefilterAutomaticallyadjuststochangesinthevesselapertureConfidential-ForInternalUseOnly-DoNotC
9、opyorDistribute.USCV5164.112.09of128FilterWireEZSystemFilter loop suspension armallowsthefilterlooptomoveindependentlyfromthewireforgoodvesselwallappositioninbothstraightandcurvedanatomySimplifiesthelandingzonerequirementsbyallowinguseinbothstraightandcurvedvesselsNoneedtotake2angioviewstoassessfilt
10、erappositionConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.010of128FilterWireEZSystemSpinnertubeunderlyingfilterassemblyAllowsthewiretorotateindependentlyfromthedeliverysheathforexcellentsystemsteerability.032”ODCatheterstopProvidesabarrierdesignedtopreventtherapeuticdevicesfromc
11、ollapsingthefilterframeLightlyvisibletocontributetovisualizationfordevicepositioning*Note:A0.013”ODpart5mmproximaltothecatheterstopmayalsobevisiblewithsomeequipment.Thispartkeepsthespinnertubeinplace,butletscathetertipspassover.Confidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.011of
12、128FilterWireEZSystem0.014”StainlesssteelwirebodywithPTFEcoatingAvailablein190cmand300cmwirelengths190cmwirelengthiscompatiblewithBSCsAddWireGuideWireSiliconecoatedondistal15cmofdevice,delivery,andretrievalsheath.Designedtoreducetheamountofforcerequiredtoloadthefilterintothedeliverysheathanddeployin
13、thevesselConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.012of128EZDeliverySheath150cmPEBAXResinsheathwith100cm,peel-awayexchangelengthThedistalsheathchangescolorfrombluetocleartoserveasawarningthatthenonpeel-awaysectionattheendofthesheathisapproaching1.1mm(0.042”or3.2F)Lesioncros
14、singprofileDistalendhasaPTFEinnerlinerInternalstoploadingfeaturealertstheoperatorthatthefilterisfullysheathedConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.013of128EZRetrievalSheath150cmPEBAXResinsheathwitha20cmlongexchangelengthSoftdistaltipDesignedtofacilitatethecapabilitytocro
15、ssdeployedstents1.4mm(0.056”or4.3F)lesioncrossingprofileInternalstopcapturefeatureAlertstheoperatorthatthefilterisfullycapturedConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.014of128EZBentTipRetrievalSheath(soldseparately)150cmPEBAXResinsheathwitha20cmexchangelengthBendatdistalti
16、pThebendisdesignedtoaidincrossingstentstrutsthatcancomplicatefilterretrieval1.3mm(0.052”or4.0F)lesioncrossingprofileInternalstopcapturefeatureAlertstheoperatorthatthefilterisfullycapturedConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.015of128FilterWire EZ Embolic Protection Syste
17、mStep-by-StepInstructionsProductDemonstrationPleaserefertotheFilterWireEZEmbolicProtectionSystemDFUforcompleteinstructionsforuse.Confidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.016of128FilterWire EZ Embolic Protection System DFU available at FilterWireEZSystemDFUCardConfidential-F
18、orInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.017of128FilterWireEZEmbolicProtectionSystemPre-Procedure1.ReviewthepatientsangiogramanddetermineifthevesselmeetstherequirementsforsafeandeffectiveuseoftheFilterWireEZSystem:a.Theapexoftheloopcanbedeployedaminimumof3.0cmfromthedistaledgeofthelesion
19、b.Thevesseldiameteratthedesiredlocationofthedeployedfilterloopis3.5mmto5.5mm.(2.25mmto3.5mmforEZSmall)3.5mm 5.5mm vessel diameterConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.018of128FilterWireEZEmbolicProtectionSystemPre-Procedure(continued)2.PriortousingtheFilterWireEZSystem,
20、anticoagulatethepatienttoachieveanACTof275secondsforcarotidapplicationsand300secondsforSVGapplications(200secondsifGPIIb/IIIainhibitorsareused).IntheabsenceofACTmeasurement,administeranappropriateweightbasedbolusofheparin(approximately125units/kg).Confidential-ForInternalUseOnly-DoNotCopyorDistribut
21、e.USCV5164.112.019of128FilterWireEZEmbolicProtectionSystemPre-Procedure(continued)RCAgraft-mostcommonlyusedguideisthemultipurpose.Marginalgraft-HockeystickguideisfirstchoicefollowedbyleftAmplatzLADorDiagonalgraft-mostcommonlyusedguidesaretheleftAmplatzandHockeystick.TakenfromMarcoet.al.“StentingofDe
22、generatedSaphenousVeinGrafts”May2001EuroPCR3.Basedonvesseltake-off,physicianshouldconsiderwhichguidecathetershapewillprovidethebestaccessandsupport.Confidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.020of128FilterWireEZEmbolicProtectionSystemPREP:DeliverySystem1.Openthepouchusingster
23、ilehandlingprocedureandplacethepackagingcoilsandaccessorykitintothesterilefield.2.Unclipandremovetheyellowhousingthatprotectsthefilter.Note:Theprotectionwireispre-loadedintothedeliverysheath.3.Detachthepre-loadedprotectionwirefromtheretainingclip,advancethedeliverysheath,thengrasptheclearsectionofth
24、esheathandremovesheathedwirefromthecoil.FilterWire EZ System Product PackagingConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.021of1284.SheaththeprotectionwireandfilterbyretractingthedeviceintotheEZDeliverySheathwhilethefilterisimmersedinheparinizedsaline.NOTE:HoldtheDeliverysheat
25、habout1cmproximaltothedarksection.NOTE:Keepthefilterunsheatheduntilimmediatelypriortouse.FilterWireEZEmbolicProtectionSystemPREP:DeliverySystem(continued)3.Attachthewiretorquerontotheproximalendoftheprotectionwire.Guide Wire TorquerConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.0
26、22of128FilterWireEZEmbolicProtectionSystemDelivery2.InserttheFilterWireEZSystemandpeel-awayintroducerassemblyintoaguidecatheter/sheath.OncetheFilterWireEZSystemisinsertedintotheguidingcatheterorguidingsheath,removethepeel-awayintroducer.NOTE:Useofaguidingcatheteroraguidingsheathwitha1.91mm(0.075”)or
27、largerrotatinghemostasisvalveisrecommendedwhenperformingaprocedurewiththeFilterWireEZSystem.Theuseofasheath/guidecatheterwithafixedhemostasisvalvemaycausethefiltermembranetotearatthehemostasisvalveuponremoval.1.Placethepeel-awayguidewireintroduceroverthetipofthedeliverysystem(thespringtipofthesystem
28、canbeshapedasneeded).Peel-away Introducer SheathConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.023of128FilterWireEZEmbolicProtectionSystemDelivery(continued)3.ToadvancetheFilterWireEZSystemthroughtheguidingcatheterorguidingsheath,useaone-handedtechniqueadvancingboththedeliveryshe
29、athandprotectionwiretogether;thiswillpreventaccidentaldeploymentofthefilter.4.TosteertheFilterWireEZSystemtothetargetlandingzone,useatwo-handedtechnique,torquingtheprotectionwirewithonehandandadvancingthedeliverysheathwiththeotherhand.NOTE:Forcarotidinterventions,havingthepatientturntheirheadtothele
30、ftorrightwillchangetheorientationofthevesselandmayfacilitatedevicepassage.NOTE:Considerusingthebuddywiretechniqueifthelesionisdifficulttopass.RetractthebuddywireafterthelesionhasbeencrossedbytheFilterWireEZSystem(Ifothereffortsareunsuccessful,pre-dilatationcanbeused.)Confidential-ForInternalUseOnly-
31、DoNotCopyorDistribute.USCV5164.112.024of128FilterWireEZEmbolicProtectionSystemDelivery(continued)5.AdvancetheFilterWireEZSystemacrossthelesionuntiltheapexofthefilterloopcanbedeployedaminimumof3.0cmdistaltothelesion.NOTE:Ifaninterventionaldevicewithatip-to-shoulderlengthofgreaterthan10.0mmistobeused,
32、alongervessellengthmayberequiredtoplacetheFilterWireEZSysteminordertoavoidcontactbetweenthefilterscatheterstopandthetipoftheinterventionaldevice.Confidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.025of1281.Oncetheprotectionwireisinplacepastthelesion,slidethetorquertipuptothehemostati
33、cvalveandtightenfirmly.2.Deploythefilterbyholdingtheprotectionwirewiththetorquer,thenretractingandcompletelyremovingthedeliverysheath.3.Besuretokeepthetorquerinplaceasyoupeel-awaythedeliverysheathinastraightmotionuntilthe3cmover-the-wiresectionisreached(seephotobelow).FilterWireEZEmbolicProtectionSy
34、stemFilterDeploymentincorrectCORRECTPhotographtakenbyBostonScientificCorporationConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.026of1284.Oncethedeliverysheathiscompletelyremoved,injectcontrastandverifythedeviceisintheproperpositionandthereisadequateflow.NOTE:Ifrepositioningisrequ
35、ired,theEZRetrievalSheathshouldbeused.Retracttheprotectionwireandfilterloopintothesheath,repositionthefilterandredeploy.5.Usetheprotectionwirelikeatraditionalguidewiretotrackcathetersandstentdeliverysystemstothetargettreatmentarea.FilterWireEZEmbolicProtectionSystemFilterDeployment(continued)Confide
36、ntial-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.027of1281.Injectcontrastfrequentlyandalwaysafteranyinterventionorexchange,tovisuallyverifythatbloodflowisnotobstructedandthatfilterloop/vesselappositiontothevesselwallismaintained.CAUTION:Ifafilterbecomesoccludedduringtheprocedure,removeita
37、nddeployasecondfilteriffurtherinterventionisrequired.2.Completetheproceduremakingsuretheprotectionwireremainsintheproperpositiondistaltothelesion(monitorfluoroscopy).Note:Failuretostabilizetheprotectionwirecouldleadtoinadvertentmovementofthefilter,resultinginprotectionwireentanglementand/ordelayinth
38、eprocedure.FilterWireEZEmbolicProtectionSystemDuringtheProcedureConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.028of128FilterWireEZEmbolicProtectionSystemFilterCaptureandRetrieval1.RemovetheEZRetrievalSheathfromitspackagingcoilandflushwithheparinizedsaline.2.Advancetheretrievalsh
39、eathovertheprotectionwirepastanydeployedstentsuptotheproximalendofthefilterloop.Note:IftheEZRetrievalSheathisnotabletopassthedeployedstent,besurethestentiswellapposedandconsiderpost-dilitation.IftheRetrievalSheathisstillunabletocross,trytheEZBentTipRetrievalSheath(availableseparately).EZ Bent Tip Re
40、trieval Sheath PackagingConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.029of128FilterWireEZEmbolicProtectionSystemFilterCaptureandRetrieval(continued)3.Gentlyandslowlyretracttheprotectionwireandfilterloopbackintotheretrievalsheathuntilresistanceisfelt.4.Observetheretrievalprocedu
41、reunderfluoroscopicimaging.Note:Thedistaledgeofthecollapsedfilterloopshouldalignwith(seefigureB),orbeproximalto(figureA),theretrievalsheathmarkerband.RetrievalSheathMarkerBandABConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.030of128FilterWireEZEmbolicProtectionSystemFilterCapture
42、andRetrieval(continued)NOTE:Ifresistanceisfeltbeforethedistaledgeofthecollapsedfilterloopisalignedwiththemarkerband,itispossiblethatthereisalargeamountofembolicdebrisinthefilter.CarefullyretracttheprotectionwireandEZRetrievalSheathasasystem.Thedistalpartofthefilterbagwillbeoutsideofthesheathduringre
43、trievalinthiscase;however,thefilterloopmustbepulledfullyintothesheath.Fully Retracted FilterLarge Debris Load in FilterConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.031of128FilterWireEZEmbolicProtectionSystemFilterCaptureandRetrieval(continued)5.Ifanyresistanceismetduringretract
44、ionofthesheathedFilterWireEZSystem,slightlyadvancethesheathedFilterWireEZSystemandrotatethesheathbeforecontinuingtoretract.6.Slowlyandcarefullyretracttheentiresystemuntilthetipoftheretrievalsheathisadjacenttothetipoftheguidingcatheterorguidingsheath.7.Ifthereisanyresistance,retracttheguidingcatheter
45、andFilterWireEZSystemtogether.Thisisdoneincasethereisalargeamountofembolicmaterialcapturedinthefilterthatmaynotfitinsidetheguidingcatheter.Confidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.032of128FilterWireEZEmbolicProtectionSystemFilterCaptureandRetrieval(continued)8.RemovetheFilt
46、erWireEZSystemfromthepatient.NOTE:Whenusinga rotatinghemostasisvalve,ensurethatthehemostasisvalveisfullyopenedpriortoFilterWireEZSystemremoval.CAUTION:Ifaguidesheathwithafixedhemostasisvalveisused,thevalvedilatortoolisrequiredforFilterWireEZSystemremoval.RemovingtheFilterWireEZSystemthroughafixedhem
47、ostasisvalvewithouttheuseofavalvedilatormaycausethefiltermembranetotear.9.Ifafixedhemostasisvalveisused,placethevalvedilator(ifprovidedintheaccessorykit)ontheshaftoftheretrievalsheathandslidethetoolintothevalve.ThenremovetheFilterWireEZSystemfromthepatientthroughthevalvedilatortoolandremovethedilato
48、r.Confidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.033of128StentEntanglementPotentialforadistalembolicprotectionfiltertoentanglewithastentisinherenttointerventionalproceduresusingthesedevices.SAFE PRACTICE FOR DISTAL PROTECTION FILTERS:1.Achievegoodguidecatheterorguidesheathsupport
49、2.Ensuresufficientlandingzone3.Keepthefilterinplaceduringdeployment4.Minimizewiremovementduringtheprocedure5.AchievefullstentappositionConfidential-ForInternalUseOnly-DoNotCopyorDistribute.USCV5164.112.034of128FilterWireEZEmbolicProtectionSystemTipsforUseKey Success Factors for Using the FilterWire
50、EZ System1.KeepACTlevels275secondsforcarotidproceduresand300secondsforSVGprocedures.2.Ifthereisdifficultycrossingthelesion,tryabuddywireand/or,forcarotidprocedures,havethepatientturntheirheadtotheleftorright.3.Forcarotidprocedures,placethefilterasdistalaspossiblewhileremainingwithintheextracranialpo
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