雅培XIENCE V依维莫司洗脱支架系统使用说明书

TheXIENCEV®EverolimusElutingCoronaryStentSystemInstructionsforUseTableofContents1.0PRODUCTDESCRIPTION1.1DeviceComponentDescription1.2DrugComponentDescription1.2.1Everolimus1.2.2InactiveIngredients–Non-erodiblePolymer1.2.3ProductMatrixandEverolimusContent2.0INDICATIONS3.0CONTRAINDICATIONS4.0WARNINGS5.0PRECAUTIONS5.1GeneralPrecautions5.2Pre-andPost-ProcedureAntiplateletRegimen5.3MultipleStentUse5.4Brachytherapy5.5UseinConjunctionwithOtherProcedures5.6UseinSpecialPopulations5.6.1Pregnancy5.6.2Lactation5.6.3Gender5.6.4Ethnicity5.6.5PediatricUse5.6.6GeriatricUse5.7Lesion/VesselCharacteristics5.8DrugInteractions5.9ImmuneSuppressionPotential5.10LipidElevationPotential5.11MagneticResonanceImaging(MRI)5.12StentHandling5.13StentPlacement5.13.1StentPreparation5.13.2StentImplantation5.14StentSystemRemoval5.15Post-Procedure6.0DRUGINFORMATION6.1MechanismofAction6.2PharmacokineticsoftheXIENCEVEverolimusElutingCoronaryStent6.3InteractionswithDrugsorOtherSubstances6.4Carcinogenicity,Genotoxicity,andReproductiveToxicityEL2066216(1/28/10)Page1of606.5Pregnancy6.6Lactation7.0OVERVIEWOFCLINICALSTUDIES8.0ADVERSEEVENTS8.1ObservedAdverseEvents8.2StentThrombosisDefinitions8.3PotentialAdverseEvents9.0XIENCEVSPIRITFAMILYOFCLINICALTRIALS9.1SPIRITIIIPivotalClinicalTrial9.1.1SPIRITIIIRandomizedClinicalTrial(RCT)9.1.2SPIRITIIIUS4.0mmArm9.2SPIRITIISupportiveClinicalTrial9.3SPIRITFIRSTRandomizedClinicalTrial9.4SPIRITIIandSPIRITIIIPooledAnalysis9.4.1StentThrombosisinSPIRITIIandSPIRITIIIPooledAnalysis9.4.2DiabeticsinSPIRITIIandSPIRITIIIPooledAnalysis9.4.3DualVesselTreatmentinSPIRITIIandSPIRITIIIPooledAnalysis10.0INDIVIDUALIZATIONOFTREATMENT11.0PATIENTCOUNSELINGANDPATIENTINFORMATION12.0HOWSUPPLIED13.0OPERATOR’SINSTRUCTIONS13.1InspectionPriortoUse13.2MaterialsRequired13.3Preparation13.3.1PackagingRemoval13.3.2GuideWireLumenFlush13.3.3DeliverySystemPreparation13.4DeliveryProcedure13.5DeploymentProcedure13.6RemovalProcedure13.7Post-DeploymentDilatationofStentSegments14.0INVITROCOMPLIANCEINFORMATION15.0REUSEPRECAUTIONSTATEMENT16.0PATENTSANDTRADEMARKSEL2066216(1/28/10)Page2of601.0PRODUCTDESCRIPTIONTheXIENCEV®EverolimusElutingCoronaryStentSystem(XIENCEVEECSSorXIENCEVstentsystem)isadevice/drugcombinationproductconsistingofeithertheMULTI-LINKVISION®CoronaryStentSystemortheMULTI-LINKMINIVISION®CoronaryStentSystemcoatedwithaformulationcontainingeverolimus,theactiveingredient,embeddedinanon-erodiblepolymer.1.1DeviceComponentDescriptionThedevicecomponentconsistsoftheMULTI-LINKMINIVISIONorMULTI-LINKVISIONstentmountedontotheMULTI-LINKMINIVISIONorMULTI-LINKVISIONstentdeliverysystem(SDS),respectively.ThedevicecomponentcharacteristicsaresummarizedinTable1-1.Table1-1:XIENCEVStentSystemProductDescriptionXIENCEVRapid-Exchange(RX)EECSSXIENCEVOver-the-Wire(OTW)EECSSAvailableStentLengths(mm)8,12,15,18,23,288,12,15,18,23,28AvailableStentDiameters(mm)2.5,2.75,3.0,3.5,4.02.5,2.75,3.0,3.5,4.0StentMaterialAmedicalgradeL-605cobaltchromium(CoCr)alloyMULTI-LINKVISIONorMULTI-LINKMINIVISIONstentDrugComponentAconformalcoatingofanon-erodiblepolymerloadedwith100μg/cm2ofeverolimuswithamaximumnominaldrugcontentof181gonthelargestent(4.0x28mm)DeliverySystemWorkingLength143cm143cmDeliverySystemDesignSingleaccessporttoinflationlumen.Guidewireexitnotchislocated30cmfromtip.Designedforguidewires≤0.014”.Sidearmadaptorprovidesaccesstoballooninflation/deflationlumenandguidewirelumen.Designedforguidewires≤0.014”.StentDeliverySystemBalloonAcompliant,taperedballoon,withtworadiopaquemarkerslocatedonthecathetershafttoindicateballoonpositioningandexpandedstentlength.BalloonInflationPressureNominalinflationpressure:8atm(811kPa)for2.5and2.75mmdiameters;9atm(912kPa)for3.0,3.5,and4.0mmdiametersRatedBurstPressure(RBP):16atm(1621kPa)forallsizesGuidingCatheterInnerDiameter≥5F(0.056”)2.5mm2.75x8–3.5x183.5x23–4.0x28CatheterShaftOuterDiameter(nominal)2.5–3.0mm3.5–4.0mmDistal:0.032”0.035”Proximal:0.026”0.026”Distal:0.032”0.034”0.036”Proximal:0.042”0.042”0.042”EL2066216(1/28/10)Page3of601.2DrugComponentDescriptionTheXIENCEVEverolimusElutingCoronaryStent(XIENCEVstent)iscoatedwitheverolimus(activeingredient),embeddedinanon-erodiblepolymer(inactiveingredient).1.2.1EverolimusEverolimusistheactivepharmaceuticalingredientintheXIENCEVstent.Itisanovelsemi-syntheticmacrolideimmunosuppressant,synthesizedbychemicalmodificationofrapamycin(sirolimus).Theeverolimuschemicalnameis40-O-(2-hydroxyethyl)-rapamycinandthechemicalstructureisshowninFigure1-1below.Figure1-1:EverolimusChemicalStructure1.2.2.InactiveIngredients–Non-erodiblePolymerTheXIENCEVstentcontainsinactiveingredientsincludingpolyn-butylmethacrylate(PBMA),apolymerthatadherestothestentanddrugcoating,andPVDF-HFP,whichiscomprisedofvinylidenefluorideandhexafluoropropylenemonomersasthedrugmatrixlayercontainingeverolimus.PBMAisahomopolymerwithamolecularweight(Mw)of264,000to376,000dalton.PVDF-HFPisanon-erodiblesemi-crystallinerandomcopolymerwithamolecularweight(Mw)of254,000to293,000dalton.Thedrugmatrixcopolymerismixedwitheverolimus(83%/17%w/wpolymer/everolimusratio)and