Silk Road Medical ENROUTE Transcarotid Stent System User manual

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InstructionsforUse
SilkRoadMedicalENROUTE®TranscarotidStentSystem
READALLINSTRUCTIONSCAREFULLY.Failuretoproperlyfollowtheinstructions,warningsandprecautionsmay
leadtoseriousconsequencesorinjurytothepatient.
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ONLYPHYSICIANSWHOHAVERECEIVEDAPPROPRIATETRAININGFORTRANSCAROTIDSTENTINGANDWHOARE
FAMILIARWITHTHEPRINCIPLES,CLINICALAPPLICATIONS,COMPLICATIONS,SIDEEFFECTSANDHAZARDS
COMMONLYASSOCIATEDWITHCAROTIDINTERVENTIONALPROCEDURESSHOULDUSETHISDEVICE.
UseonlywithENROUTETranscarotidNeuroprotectionSystem(NPS).
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EOSTERILE.ENROUTETranscarotidStentSystemissterilizedwithethyleneoxide(EO)gas.
Non‐pyrogenic.
DONOTUSETHISPRODUCTWITHPOWERINJECTIONSYSTEMS.
FORONEUSEONLY.
DONOTRESTERILIZE.
DONOTUSETHISPRODUCTPASTITSEXPIRATIONDATE.
THISPRODUCTISRADIOPAQUE.
STOREINACOOL,DARK,DRYPLACE.
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InstructionsforUse,ENROUTETranscarotidStentSystem,TableofContents
1.0 DeviceName
2.0Description
3.0 IndicationsforUse
4.0 Contraindications
5.0 Warnings
5.1 GeneralWarnings
5.2 PatientSelectionWarnings
5.3 DeviceUseWarnings
6.0 Precautions
6.1 StentHandlingPrecautions
6.2 StentPlacementPrecautions
6.3 PostStentPlacementPrecautions
6.4 MRISafetyInformation
7.0 AdverseEvents
7.1 ObservedAdverseEvents–ClinicalStudies
7.2 ROADSTERStudy–Sub‐StudyofPatientsTreatedwithaCombinationofthePRECISEStentSystemand
theENROUTETranscarotidNeuroprotectionSystem
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Caution:Federallawrestrictsthisdevicetosale
byorontheorderofaphysician

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7.3 PROOFPivotalStudy–Sub‐StudyofPatientsTreatedwithaCombinationofthePRECISEStentSystem
andtheENROUTETranscarotidNeuroprotectionSystem
7.4 PotentialAdverseEvents
7.5 DeviceRelatedAdverseEventReporting
8.0 ClinicalStudyInformation
8.1 TheROADSTERStudy
9.0 DirectionsforUse
9.1 Peri‐ProceduralCare
9.2 Pre‐Procedure
9.3 DeviceSelectionandPreparation
9.4 StentDeploymentProcedure
10.0 DisclaimerofWarrantyandLimitationofRemedy
11.0 LicenseandPatentDisclosure
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1.0DeviceName
ThedevicebrandnameistheENROUTE®TranscarotidStentSystem.
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2.0Description
TheENROUTETranscarotidStentSystemconsistsofanitinolself‐expandingstentpreloadedona5F(.065"/1.65
mm)or6F(.078"/1.98mm)sheatheddeliverysystem.Therapidexchangedeliverysystemconsistsmainlyofan
innershaftandanoutersheathwithradiopaquemarkers,andaTuohyBorstvalve.Theinnershaftconsistsofa
supportmemberandwirelumen.Theproximalportionofthesupportmemberiscomprisedofahubconnectedto
astainlesssteelwireandhypotubeanddistallyofastainlesssteelcoil.Thewirelumenoriginatesdistallyina
cathetertipandterminatesproximallyataguidewireexitportdesignedtoaccepta.014"(0.36mm)guidewire.
Theoutersheathhasaproximalshaftanddistaloutersheathwithanominalworkinglengthof57cm.Theself‐
expandingENROUTETranscarotidStentSystemisconstrainedwithinthespacebetweentheinnershaftandthe
distaloutersheath,locatedbetweendistalandproximalstentmarkersontheinnershaft.Thestentexpandstoits
unconstraineddiameterwhenreleasedfromthedeploymentcatheterintothecarotidartery.Upondeployment,
thestentformsalatticetocoverthediseasedarterialsegmentandtopushoutwardontheluminalsurface,
helpingtomaintainthepatencyoftheartery.Duetotheself‐expandingbehaviorofnitinol,thestentsare
indicatedforplacementintovesselsthatare1‐2mmsmallerindiameterthantheunconstraineddiameterofthe
stent.DevicedepictionsandcomponentsareprovidedinFigure1.
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Figure1.ENROUTETRANSCAROTIDSTENTSYSTEM
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1.TuohyBorstvalve
2.Hypotube
3.Coil
4.CatheterInnerShaftTip
5.InnerShaftHub
6A.ProximalShaft
6B.DistalOuterSheath
7.OuterSheathLuerHub
8.PodHousingCrimpedStent
9.TuohyBorstY‐Connection
10.ProximalInnerShaftMarker(Stop)Marks
11.OuterSheathRadiopaqueMarker
12.ProximalValveEnd
13.DistalInnerShaftStentMarker
14.CoilSleeve
15.WireLumen
16.GuidewireExitPort
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TheENROUTETranscarotidStentSystemisprovidedasnotedinTable1below.

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Table1
ENROUTETranscarotidStentSystem
57cmWorkingLength
GuidewireLumen:Accepts.014”(0.36mm)Guidewire
ForusewithENROUTETranscarotidArterialSheath(8FID,2.7mm)
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.065"(1.65mm)
ENROUTE
CODES
UNCONSTRAINEDSTENT
DIMENSIONS
DiameterxLength(mm)
CROSSINGPROFILE
SR‐0520‐CS5x20 5F(.078",1.98mm)
SR‐0530‐CS5x30 5F(.078",1.98mm)
SR‐0540‐CS5x40 5F(.078",1.98mm)
SR‐0620‐CS6x20 5F(.078",1.98mm)
SR‐0630‐CS6x30 5F(.078",1.98mm)
SR‐0640‐CS6x40 5F(.078",1.98mm)
SR‐0720‐CS7x20 5F(.078",1.98mm)
SR‐0730‐CS7x30 5F(.078",1.98mm)
SR‐0740‐CS7x40 5F(.078",1.98mm)
SR‐0820‐CS8x20 5F(.078",1.98mm)
SR‐0830‐CS8x30 5F(.078",1.98mm)
SR‐0840‐CS8x40 5F(.078",1.98mm)
SR‐0920‐CS9x20 6F(.087",2.21mm)
SR‐0930‐CS9x30 6F(.087",2.21mm)
SR‐0940‐CS9x40 6F(.087",2.21mm)
SR‐1020‐CS10x20 6F(.087",2.21mm)
SR‐1030‐CS10x30 6F(.087",2.21mm)
SR‐1040‐CS10x40 6F(.087",2.21mm)
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3.0IndicationsforUse
TheENROUTETranscarotidStentSystemusedinconjunctionwiththeENROUTETranscarotidNeuroprotection
System(NPS)isindicatedforthetreatmentofpatientsathighriskforadverseeventsfromcarotid
endarterectomy,whorequirecarotidrevascularizationandmeetthecriteriaoutlinedbelow.
1.Patientswithneurologicalsymptomsand>50%stenosisofthecommonorinternalcarotidarterybyultrasound
orangiogramORpatientswithoutneurologicalsymptomsand>80%stenosisofthecommonorinternalcarotid
arterybyultrasoundorangiogram,AND
2.Patientsmusthaveavesseldiameterof4‐9mmatthetargetlesion,AND
3.Carotidbifurcationislocatedatminimum5cmabovetheclavicletoallowforplacementoftheENROUTE
TranscarotidNPS.
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4.0Contraindications
UseoftheENROUTETranscarotidStentSystemiscontraindicatedinthefollowingpatients:
1.Patientsinwhomantiplateletand/oranticoagulationtherapyiscontraindicated.
2.PatientsinwhomtheENROUTETranscarotidNPSisunabletobeplaced.
3.Patientswithuncorrectedbleedingdisorders.
4.Patientswithknownallergiestonitinol.
5.Lesionsintheostiumofthecommoncarotidartery.
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5.0Warnings
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5.1GeneralWarnings
1.Onlyphysicianswhohavereceivedappropriatetrainingfortranscarotidstentingandwhoarefamiliarwiththe
principles,clinicalapplications,complications,sideeffectsandhazardscommonlyassociatedwithcarotid
interventionalproceduresshouldusethisdevice.
2.ThesafetyandefficacyoftheENROUTETranscarotidStentSystemhavenotbeendemonstratedwithembolic
protectionsystemsotherthantheENROUTETranscarotidNPS.UsetheENROUTETranscarotidStentSystemonly
withtheENROUTETranscarotidNPS.
3.Thelongtermperformance(>3years)ofcarotidstentshasnotyetbeenestablished.
4.Aswithanytypeofvascularimplant,infectionsecondarytocontaminationofthestentmayleadtothrombosis,
pseudoaneurysmorrupture.
5.Thestentmaycauseathrombus,distalembolizationormaymigratefromthesiteofimplantthroughthe
arteriallumen.Appropriatesizingofthestenttothevesselisrequiredtoreducethepossibilityofstentmigration
(seeSection9.3oftheseinstructions).Intheeventofthrombosisoftheexpandedstent,thrombolysisandPTA
shouldbeattempted.
6.Overstretchingofthearterymayresultinruptureandlife‐threateningbleeding.
7.Inpatientsrequiringtheuseofantacidsand/orH2‐antagonistsbeforeorimmediatelyafterstentplacement,
oralabsorptionofantiplateletagents(e.g.aspirin)maybeadverselyaffected.
8.Theappropriateantiplateletandanticoagulationtherapyshouldbeadministeredpre‐andpost‐procedureas
suggestedinSection9.1oftheseinstructions.
9.Intheeventofcomplicationssuchasinfection,pseudoaneurysmorfistulization,surgicalremovalofthestent
mayberequired.
5.2PatientSelectionWarnings
1.SafetyandeffectivenessoftheENROUTETranscarotidStentSystemhasNOTyetbeenestablishedinpatients
withthecharacteristicsnotedbelow.
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LesionCharacteristics:
•Patientswithevidenceofintraluminalthrombusthoughttoincreasetheriskofplaquefragmentationanddistal
embolization.
•Patientswhoselesion(s)mayrequiremorethantwostents.
•Patientswithtotalocclusionofthetargetvessel.

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•Patientswithlesionsoftheostiumofthecommoncarotid.
•PatientswithhighlycalcifiedlesionsresistanttoPTA.
•Concurrenttreatmentofbilaterallesions.
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PatientCharacteristics:
•Patientsatlow‐to‐moderateriskforadverseeventsfromcarotidendarterectomy.
•Patientsexperiencingacuteischemicneurologicstrokeorwhoexperiencedastrokewithin48hours.
•Patienthashadarecent(<7days)strokeofsufficientsize(onCTorMRI)toplacehimorheratriskof
hemorrhagicconversionduringtheprocedure.
•Patientswithipsilateralintracranialorextracranialarterialstenosisgreaterinseveritythanthelesiontobe
treated,cerebralaneurysm>5mm,AVM(arteriovenousmalformation)ofthecerebralvasculature,orintracranial
tumor.
•Patientswitharterio‐venousmalformationsintheterritoryofthetargetcarotidartery.
•Patientswithdiathesisorcoagulopathies.
•Patientswithpoorrenalfunction,who,inthephysician’sopinion,maybeathighriskforareactiontocontrast
medium.
•Patientswithperforatedvesselsevidencedbyextravasationofcontrastmedia.
•Patientswithaneurismaldilationimmediatelyproximalordistaltothelesion.
•Pregnantpatientsorpatientsundertheageof18.
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AccessCharacteristics:
•Patientswithknowninternalcarotidarterytortuositythatwouldprecludetheuseofcatheter‐basedtechniques.
•Patientswithknowncommoncarotidorinternalcarotidarterytortuositythatwouldprecludetheuseof
catheter‐basedtechniques.
•Patientsinwhomcommoncarotidaccessisnotpossible.

2.RiskofdistalembolizationmaybehigheriftheENROUTETranscarotidStentSystemcannotbeusedin
conjunctionwiththeENROUTETranscarotidNPSduringthecarotidstentingprocedure.

5.3DeviceUseWarnings
1.USEOFASMALLERTHANINDICATEDACCESSORYDEVICEOTHERTHANTHEENROUTETRANSCAROTID
ARTERIALSHEATHMAYLEADTOINTRODUCTIONOFAIRINTOTHATDEVICEASTHESTENTDELIVERYSYSTEMIS
ADVANCED,WHICHMAYNOTBEREMOVEDDURINGAIRASPIRATION.
2.Ensurethatthecathetersystemisflushedaccordingtothestepsoutlinedin"IntroductionofStentDelivery
System"(Section9.4).FailuretodosocouldresultinairenteringtheENROUTE’sTranscarotidArterialSheath.
3.EnsurethatthereisatightsealbetweentheENROUTEcatheterandthevalvefortheENROUTETranscarotid
ArterialSheathduringaspiration.FailuretodosocouldresultinairenteringtheENROUTETranscarotidArterial
Sheath.
4.Theblackdottedpatternonthegraytemperatureexposureindicatorfoundonthepouchmustbeclearly
visible.
DONOTUSETHEPRODUCTIFTHEENTIRETEMPERATUREEXPOSUREINDICATORISCOMPLETELYBLACKasthe
pre‐programmedstentdiametermayhavebeencompromised.
5.Donotusethedeviceifthereareabnormalitiesinthesterilebarrier(e.g.brokenseal,tornorbreachedbarrier)
ortheproduct.
6.Thisdeviceisintendedforone‐timeuseonly.Donotre‐sterilizeand/orreuse.Structuralintegrityand/or
functionmaybeimpairedthroughreuseorcleaning.
7.DonotusetheENROUTETranscarotidStentSystemafterthe“UseBy”datespecifiedonthepackage.
8.DonotusewithEthiodolorLipiodol*contrastmedia,whichmayadverselyaffectthestentdeliverysystem.
*EthiodolandLipiodolareTrademarksofGerbertS.A.
9.Donotexposethedeliverysystemtoorganicsolvents(e.g.,alcohol)asstructuralintegrityand/orfunctionofthe
devicemaybeimpaired.



10.Thestentisnotdesignedfordraggingorrepositioning.
11.Oncethestentispartiallydeployed,itcannotberecapturedusingthestentdeliverysystem.
12.Aswithanytypeofvascularimplant,infectionsecondarytocontaminationofthestentmayleadto
thrombosis,pseudoaneurysmorrupture.
13.Whenmultiplestentsareused,theyshouldbeofsimilarcomposition.
14.Long‐termoutcomesfollowingrepeatdilatationofendothelializedstentsareunknown.


6.0Precautions

6.1StentHandlingPrecautions
1.TheENROUTETranscarotidStentSystemissuppliedSTERILEandisintendedforsingleuseonly.DONOT
resterilizeand/orreusethedevice.
2.TheENROUTETranscarotidStentSystemisshippedwiththeTuohyBorstvalveintheOPENposition.Care
shouldbetakennottopre‐deploythestent.Thedeviceshouldbepreppedinthetray.(SeeSection9.3ofthese
instructions).
3.DonotusetheENROUTETranscarotidStentSystemafterthe"UseBy"datespecifiedonthepackage.
4.Donotuseifthepouchisopenedordamaged.
5.Storeinacool,dark,dryplace.

6.2StentPlacementPrecautions
1.Venousaccessshouldbeavailableduringcarotidstentinginordertomanagebradycardiaand/orhypotension
eitherbypharmaceuticalinterventionorplacementofatemporarypacemaker,ifneeded.
2.Whencathetersareinthebody,theyshouldbemanipulatedonlyunderfluoroscopy.Radiographicequipment
thatprovideshighqualityimagesisneeded.
3.Thedeliverysystemisnotdesignedfortheuseofpowerinjection.Useofpowerinjectionmayadverselyaffect
deviceperformance.
4.Ifresistanceismetduringdeliverysystemintroduction,thesystemshouldbewithdrawnandanothersystem
used.
5.Priortostentdeployment,removeallslackfromthecatheterdeliverysystem(seeSection9.4,4ofthese
instructions).
6.Adequatedistancemustbemaintainedfromthedistaltipofthetranscarotidaccesssheathandtheproximal
edgeofthestenttoavoidstentdeliverywithinthelumenofthesheath.
7.Whentreatingmultiplelesions,thedistallesionshouldbeinitiallystented,followedbystentingoftheproximal
lesion.Stentinginthisorderobviatestheneedtocrosstheproximalstentinplacementofthedistalstentand
reducesthechancefordislodgingstentsthathavealreadybeenplaced.
8.Overlapofsequentialstentsisnecessary,buttheamountofoverlapshouldbekepttoaminimum
(approximately5mm).Innoinstanceshouldmorethan2stentsoverlap.
9.Fracturesofthisstentmayoccur.Fracturesmayalsooccurwiththeuseofmultipleoverlappingstents.
Fractureshavebeenreportedmostofteninclinicalusesforwhichthesafetyandeffectivenesshavenotbeen
established.Thecausesandclinicalimplicationsofstentfracturesarenotwellcharacterized.Careshouldalsobe
takenwhendeployingthestentasexcessiveforcecould,inrareinstances,leadtostentdeformationand/or
fracture.

6.3PostStentPlacementPrecautions
1.Recrossingadeployedstentwithadjunctdevicesmustbeperformedwithcaution.
2.Intheeventofthrombosisoftheexpandedstent,thrombolysisandPTAshouldbeattempted.



6.4MRISafetyInformation

Non‐clinicaltestinghasdemonstratedthattheENROUTETranscarotidStentisMRConditional.Apatientwiththis
devicecanbescannedsafelyinanMRsystemmeetingthefollowingconditions:
‐Staticmagneticfieldof1.5‐Teslaor3‐Tesla,only
‐Maximumspatialgradientmagneticfieldof4,000Gauss/cm(40Tesla/m)orless
‐MaximumMRsystemreported,wholebodyaveragedspecificabsorptionrate(SAR)of2‐W/kg(NormalOperating
Mode).

Underthescanconditionsdefinedabove,theENROUTETranscarotidStentisexpectedtoproduceamaximum
temperatureriseof2.4°Cafter15minutesofcontinuousscanning.

Innon‐clinicaltesting,theimageartifactcausedbythedeviceextendsapproximately5mmfromtheENROUTE
TranscarotidStentwhenimagedwithagradientechopulsesequenceanda3‐TeslaMRIsystem.Theartifactdoes
obscurethedevicelumen.

7.0AdverseEvents
TheENROUTETranscarotidStentSystemisastentingplatformbasedupontheFDA‐approvedCordisPRECISE
NitinolStentSystem(PRECISE).TheENROUTETranscarotidStentSystemisidenticaltothePRECISEStentSystem
withtheexceptionoftheworkinglengthofthedeliverysystem.TheENROUTETranscarotidStentSystemhasa
workinglengthof57cmwhereasthePRECISEStentSystemhasaworkinglengthof135cm.Theadverseevent
informationpresentedhereinencompassesclinicaltrialdataontheuseofthePRECISEStentSystemin
combinationwiththeENROUTETranscarotidNPS(seeSection7.1,ObservedAdverseEvents).Additionaladverse
eventinformationisderivedfromclinicaltrialdataontheuseofthePRECISEStentSystemandtheANGIOGUARD®
XPEmboliCaptureGuidewire.
7.1ObservedAdverseEvents–ClinicalStudies
CarotidstentingwithreverseflowproximalembolicprotectionusingthePRECISEStentSystemandtheENROUTE
TranscarotidNeuroprotectionSystemwasconductedin65patientsintheROADSTERstudy(n=52)andthePROOF
study(n=13).IntheROADSTERstudy,asub‐studyof52patientswhowereathighriskforcomplicationsfrom
carotidendarterectomy(CEA)wereenrolledtoevaluatethesafetyandeffectivenessofthePRECISEStentSystem
whenusedwiththeENROUTETranscarotidNeuroprotectionSystem.InthePROOFStudy,13patientswhowereat
standardandhighriskforcomplicationsfromCEAwereenrolledtoevaluatethefeasibilityofthecarotid
angioplastyandstentingwithENROUTETranscarotidNPS.Thesedataserveasthebasisforthesafetyand
effectivenessoftheENROUTETranscarotidStentSystemwhichdiffersfromthePRECISEStentSystemonlyinthe
workinglengthofthedeliverysystem.SafetyandeffectivenessdataforthePRECISEStentSystemwhenusedwith
theANGIOGUARDXPEmboliCaptureGuidewirecanbefoundonFDA’swebsiteatthefollowingURL:
http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030047b.pdf.510(k)clearanceoftheENROUTETranscarotid
NPSwassupportedbydatafromthefullcohortofpatientsenrolledintheROADSTERstudy(n=141)whenused
withanyFDA‐approvedcarotidstentsystem.
TheMajorAdverseEventrateintheROADSTERsub‐studypopulation(subjectstreatedwithacombinationofthe
PRECISEStentandtheENROUTETranscarotidNPS)was1.9%.Onesubjectexperiencedaminoripsilateralstroke
withinthe30‐dayfollow‐upperiod.




7.2ROADSTERStudy–Sub‐StudyofPatientsTreatedwithaCombinationofthePRECISEStentSystemandthe
ENROUTETranscarotidNeuroprotectionSystem
Thisprospective,singlearm,multi‐centerstudyincluded52patientsathighriskforcomplicationsfromCEA.The
PRECISEStentSystemwasusedasasurrogatefortheENROUTETranscarotidStentSystemasthetwosystems
differonlyintheworkinglength.Themajoradverseevent(MAE)ratewasdefinedasdeath,stroke,orMIto30
days.The30‐dayMAErateforthesepatientswas1.9%.Seriousadverseeventsto30daysfromtheROADSTER
sub‐studyarepresentedinthefollowingtable:
Table2
SeriousAdverseEventsto30Days
SystemOrganClass
PreferredTerm
AllPRECISEStentSubjects in
ROADSTER
(N=52)
Number(%)ofSubjectswithoneormoreSeriousAdverseEvents 7(13.5%)
BloodAndLymphaticSystemDisorders1(1.9%)
Anaemia1(1.9%)
CardiacDisorders1(1.9%)
CardiacFailureCongestive1(1.9%)
Injury,PoisoningAndProceduralComplications 1(1.9%)
PostProceduralHaemorrhage1(1.9%)
NervousSystemDisorders1(1.9%)
CerebrovascularAccident1(1.9%)
Respiratory,ThoracicAndMediastinalDisorders 1(1.9%)
Atelectasis1(1.9%)
VascularDisorders2(3.8%)
ArteryDissection1(1.9%)
Hypotension1(1.9%)

ResultsfromtheROADSTERsub‐studyofsubjectsreceivingthePRECISEstent(N=52)werecomparabletoresults
seenintheROADSTERpivotalstudycohort(N=141).

7.3PROOFPivotalStudy–Sub‐StudyofPatientsTreatedwithaCombinationofthePRECISEStentSystemand
theENROUTETranscarotidNeuroprotectionSystem
Thisprospective,singlearm,multi‐centerstudyincluded13patientsatstandardandhighriskforcomplications
fromCEA.ThePRECISEStentSystemwasusedasasurrogatefortheENROUTETranscarotidStentSystemasthe
twosystemsdifferonlyintheworkinglength.Themajoradverseevent(MAE)ratewasdefinedasdeath,major
stroke,orMIto30days.Itshouldbenotedthat,althoughtheprimaryendpointforstrokeincludedonlymajor
stroke,therewerenominorstrokesinthissub‐studypopulation.The30‐dayMAErateforthesepatientswas
0.0%.Seriousadverseeventsto30daysfromthePROOFsub‐studyarepresentedinthefollowingtable:









Table3
ENROUTETranscarotidStentSystem
SeriousAdverseEvents
SystemOrganClassAll PRECISEStentSubjectsinPROOF
(N=13)
Number(%)ofSubjectswithoneormore Serious AdverseEvents 13(100%)
CardiacDisorders2(15.4%)
GastrointestinalDisorders2(15.4%)
GeneralDisordersandAdministrationSiteConditions 1(7.7%)
InfectionsandInfestations1(7.7%)
Investigations2(15.4%)
NervousSystemDisorders7(53.8%)
Respiratory,Thoracic,andMediastinalDisorders 1(7.7%)
SkinandSubcutaneousTissueDisorders2(15.4%)
SurgicalandMedicalProcedures1(7.7%)
VascularDisorders7(53.8%)


7.4PotentialAdverseEvents
AdverseEvents(inalphabeticalorder)thatmaybeassociatedwiththeuseoftheENROUTETranscarotidStent
SystemwhenusedinconjunctionwiththeENROUTETranscarotidNPSinclude,butmaynotbelimitedto(based
uponclinicaltrialdataforthePRECISE Stent System and the ANGIOGUARD XP Emboli Capture Guidewire and
clinical trial data from the ROADSTER and PROOF studies):
•Airembolism
•Allergic/anaphylactoidreaction
•Anemia
•Aneurysm
•Angina/coronaryischemia
•Arrhythmia(includingbradycardia,possiblyrequiringneedforatemporaryorpermanentpacemaker)
•Arterialdissection
•Arterialocclusion/restenosisofthetreatedvessel
•Arterialocclusion/thrombus,atpuncturesite
•Arterialocclusion/thrombus,remotefrompuncturesite
•Arteriovenousfistula
•Atelectasis
•Atrialfibrillation
•Bacteremiaorsepticemia
•Cerebraledema
•CongestiveHeartFailure
•Death
•Embolization,arterial
•Embolization,stent
•Emergentrepeathospitalintervention
•Fever
•Gastrointestinaldisorders
•GIbleedingfromanticoagulation/antiplateletmedication
•Hallucination
•Hematomableed,accesssite
•Hematomableed,remotesite



•Hemorrhage
•Hyperperfusionsyndrome
•Hypotension/hypertension
•Hypomagnesaemia
•Hypophoshatemia
•Infection
•Intimalinjury/dissection
•Ischemia/infarctionoftissue/organ
•Localinfectionandpainatinsertionsite
•Malposition(failuretodeliverthestenttotheintendedsite)
•Myocardialinfarction
•Nausea
•Oxygensaturationdecrease
•Pain
•Pseudoaneurysm
•Rales
•Renalfailure
•Respiratoryinfection
•Restenosisofthevessel(>50%obstruction)
•Rhinorrhea
•Seizure
•Severeunilateralheadache
•Stentmigration
•Stentthrombosis
•Stroke
•Transientischemicattack
•Transientintolerancetoreverseflow
•Urinarytractinfection
•Vasospasm
•Venousocclusion/thrombosis,atpuncturesite
•Venousocclusion/thrombosis,remotefrompuncturesite
•Vesselrupture,dissection,perforation
•Vomiting
•Wheezing

7.5DeviceRelatedAdverseEventReporting
Anyadverseevent(clinicalincident)involvingtheENROUTETranscarotidStentSystemshouldbereportedtoSilk
RoadMedical,Inc.immediately.Toreportanincident,callSilkRoadMedical,Inc.at408‐720‐9002.

8.0ClinicalStudyInformation
TheROADSTERclinicalstudywasconductedtoevaluatethesafetyandeffectivenessofthePRECISEStentSystem
whenusedwiththeENROUTETranscarotidNPS.ThePRECISEStentSystemwasusedasasurrogateforthe
ENROUTETranscarotidStentSystemasthetwosystemsdifferonlyintheworkinglength.TheROADSTERpivotal
studydataarepresentedbelow.
8.1TheROADSTERStudy
TheROADSTERstudywasaprospective,single‐arm,multi‐centerclinicaltrialoftheENROUTETranscarotidNPSin
conjunctionwithallFDA‐approvedcarotidarterystentsincludingthePRECISEStentSystemusedfor
revascularizationinpatientswithcarotiddiseasewhowereathighriskforcomplicationsfromcarotid
endarterectomy(CEA).Therewasalead‐inphaseofuptofive(5)patientsperinvestigatortoallowinvestigators
togainexperiencewiththestudydevicepriortopivotalstudyenrollment.Sixty‐seven(67)lead‐inand141pivotal



(ITT)subjectsathighriskforcomplicationsfromCEAwereenrolledbetweenNovember2012andJuly2014.Asub‐
studyof18lead‐inand34pivotalsubjectsathighriskforcomplicationsfromCEAandtreatedwiththePRECISE
StentSystemwasalsoconducted.Thestudyincludedpatientswithatheroscleroticextracranialinternalcarotid
stenosis(ICA)withorwithoutinvolvementofthecontiguouscommonartery(CCA)determinedbyduplex
ultrasound,CT/CTA,MR/MRAorangiography.Thestudypopulationconsistedofmaleandfemalesubjectsatleast
18yearsofagemeetingoneofthefollowingcriteriaregardingneurologicalsymptomstatusanddegreeof
stenosis:
Symptomatic:Stenosismustbe>50%asdeterminedbyangiogramandthepatienthasahistoryofstroke
(minorornon‐disabling),TIAand/oramaurosisfugaxwithin180daysoftheprocedure,OR
Asymptomatic:Stenosismustbe>70%asdeterminedbyangiogramwithoutanyneurologicalsymptoms
withintheprior180days.
EligiblesubjectswerescheduledtoundergocarotidrevascularizationanyFDA‐approvedcarotidarterystent
systemwiththeENROUTETranscarotidNPS.Subjectswerefollowedfor30dayspost‐procedure.Patientsmetat
leastoneofthesurgicalhigh‐riskcriterialistedbelow.
AnatomicHighRiskInclusionCriteria:
A. Contralateralcarotidarteryocclusion
B. Tandemstenoses>70%
C. Highcervicalcarotidarterystenosis
D. Restenosisaftercarotidendarterectomy
E. Bilateralcarotidarterystenosisrequiringtreatment(Treatmentofthecontralateralvessel
mustbescheduledatleast30dayspostindexprocedure).
F. HostileNeckswhichtheInvestigatordeemssafefortranscarotidaccessincluding:
I. Priorneckirradiation
II. Radicalneckdissection
III. Cervicalspineimmobility
ClinicalHighRiskInclusionCriteria:
G. Patientis75yearsofage
H. Patienthas>2‐vesselcoronaryarterydiseaseandhistoryofangina
I. Patienthasahistoryofangina
CanadianCardiovascularSociety(CCS)anginaclass3or4
 or
unstableangina
J. Patienthascongestiveheartfailure(CHF)‐NewYorkHeartAssociation(NYHA)
FunctionalClassIIIorIV
K. Patienthasknownsevereleftventriculardysfunction
LVEF<30%.
L. Patienthashadamyocardialinfarction>72hoursand<6weekspriortoprocedure.
M. Patienthasseverepulmonarydisease(COPD)witheither:
FEV1<50%predictedor
chronicoxygentherapyor
restingPO2of60mmHg(roomair)
N. Patienthaspermanentcontralateralcranialnerveinjury
O. Patienthaschronicrenalinsufficiency(serumcreatinine>2.5mg/dL).
Thefollowingeffectivenessendpointswereassessed0to30daysinthelead‐inandITTpivotalpopulations
comprisedofsubjectsdeemedtobeathighriskforcomplicationsfromCEAandtreatedwiththePRECISEStent
System:
AcuteDeviceSuccess
TechnicalSuccess
ProceduralSuccess
Thefollowingsafetyendpointswereassessed0to30daysinthelead‐inandITTpopulationscomprisedofsubjects
deemedtobeathighriskforcomplicationsfromCEAandtreatedwiththePRECISESystem:



MajorAdverseEvents(stroke,deathandmyocardialinfarction)
AdverseEvents
AccessSiteComplications
Compulsoryclinicalfollow‐upincludedneurologicalexaminations(NIHStrokeScale,BarthelADLIndex,Modified
RankinScale,andCranialNervePalsyassessment),duplexultrasound,andlaboratoryassessmentsofcardiac
enzymesand12‐leadEKG.Subjectswhoweresuspectedofhavingastrokewereaskedtoreturnat3monthspost‐
procedureforafollow‐upneurologicalexam.Subjectssuspectedofhavingaprocedurerelatedcranialnerveinjury
wereaskedtoreturnat6monthspost‐procedureforafollowupneurologicalexamination.

Patientfollow‐upandaccountabilityarepresentedinthefollowingtableforthesub‐studypopulation:


Table4
PatientFollow‐UpandAccountability
30‐DayFollow‐Up90‐DayFollow‐Up16‐MonthFollow‐Up2
N%N % N %
52/52100%1/1 100% N/A N/A

Patientdemographicsinthesub‐studypopulationarepresentedinthefollowingtable:


Table5
PatientDemographicsintheSub‐StudyPopulation
ObservationAllPRECISEStentPatients inROADSTER
(N=52)
Age(Years)73.0±9.07
Symptomatic23.1%
Male57.7%
Diabetes34.6%
Hypertension94.2%
HistoryofPeripheralArteryDisease 34.6%
HistoryofCoronaryArteryDisease 48.1%
HistoryofAngina19.2%
CongestiveHeartFailure11.5%
RecentMI1.9%
SeverePulmonaryDisease 9.6%
Dyslipidemia88.5%
HistoryofStroke15.4%
HistoryofTIA21.2%
HistoryofAmaurosisFugax 13.5%
CurrentNicotineUse25.0%
Age>75Years51.9%
Age>80Years23.1%
ContralateralCarotidOcclusion 9.6%
HighCervicalCarotidStenosis 15.4%
RestenosisafterCEA28.8%

1Foronlythosesubjectssuspectedofhavingastroke.
2ForonlythosepatientssuspectedofhavingaCranialNerveInjury(CNI)



BilateralStenosisRequiringTreatment 32.7%
HostileNeck15.4%
>2VesselCoronaryDisease 7.7%
ChronicRenalInsufficiency 1.9%


Theprimaryeffectivenessoutcomesincludeacutedevicesuccess,technicalsuccess,andproceduralsuccess.In
thesub‐studypopulation,acutedevicesuccesswasdefinedastheabilitytoinsertthedevice,establishflow
reversal,andremovethedevicewas100%.Technicalsuccessdefinedasacutedevicesuccessplustheabilityto
deliverinterventionaltoolswas100%inthesub‐studypopulation.Proceduralsuccessdefinedastechnicalsuccess
intheabsenceofaMajorAdverseEvent(S/D/MI)was98.1%inthesub‐studypopulation.

Table6:ROADSTERSub‐study‐SummaryofBaselineVesselandLesionCharacteristics
ObservationAllPRECISEStentSubjects
(n=52)
TargetLesionLocation
Left27(51.9%)
Right25(48.1%)
VesseltobeTreated
ICA37(71.2%)
ICA+CCA15(28.8%)
Distancebetweenclavicleandbifurcation(cm)
N52
Mean6.6
StandardDeviation 1.21
Median6.5
Minimum,Maximum 5,10
95%ConfidenceInterval (6.3,6.9)
TargetVesselCalcification
Normal26(50.0%)
Mild17(32.7%)
Moderate6(11.5%)
Severe 1(1.9%)
Unknown/NA 2(3.8%)
TargetVesselTortuosity
Normal10(19.2%)
Mild26(50.0%)
Moderate10(19.2%)
Severe2(3.8%)
Unknown/NA 4(7.7%)
Pre‐ProcedureVesselDiameter(mm)
N52
Mean6.7
StandardDeviation 1.78
Median6.8
Minimum,Maximum 4,11
95%ConfidenceInterval (6.2,7.2)
TargetLesionLength(mm)
N52
Mean18.7



ObservationAllPRECISEStentSubjects
(n=52)
StandardDeviation 8.05
Median17.6
Minimum,Maximum 5,39
95%ConfidenceInterval (16.4,20.9)
Pre‐ProcedurePercentStenosis(%)
N52
Mean86.1
StandardDeviation 9.01
Median90.0
Minimum,Maximum 60,99
95%ConfidenceInterval(83.6,88.6)


Table7
AcuteDevice,TechnicalandProceduralSuccessinSubjectsTreatedwiththePRECISEStent
ObservationsAllPRECISEStentSubjects
(N=52)
AcuteDeviceSuccess52(100%)
TechnicalSuccess52(100%)
ProceduralSuccess51(98.1%)


TheMajorAdverseEventrateinthesub‐studypopulation(subjectstreatedwithacombinationofthePRECISE
StentSystemandtheENROUTETranscarotidNPS,N=52)was1.9%.Onesub‐studysubjectexperiencedaminor
ipsilateralstrokewithinthe30‐dayfollow‐upperiod.ThefollowingtablepresentstheMajorAdverseEventratein
thesub‐studypopulationalongwithotherendpointsfromtheROADSTERstudy:

Table8
MajorAdverseEventRate
Observations
(at30days)
AllPRECISEStentPatientsinROADSTER
(N=52)
PRIMARYENDPOINTS
Safety:
30DayMAE(Stroke,Death,orMI) 1(1.9%)
Effectiveness:
AcuteDeviceSuccess52(100%)
TechnicalSuccess52(100%)
ProceduralSuccess51(98.1%)
SECONDARYENDPOINTS
AllDeath(non‐hierarchical)0(0.0%)
AllStroke(non‐hierarchical)1(1.9%)
AllMyocardialInfarction(non‐
hierarchical)
0(0.0%)
AllCardiacDeath(non‐hierarchical) 0(0.0%)
IpsilateralStroke(non‐hierarchical) 1(1.9%)
AccessSiteComplications
Oozing0(0.0%)



Observations
(at30days)
AllPRECISEStentPatientsinROADSTER
(N=52)
LimitedSurgicalWound
Hematoma
0(0.0%)
SurgicalWoundHematoma 0(0.0%)
ArterialAccessSiteHematoma 0(0.0%)
FemoralVeinAccessSite
Hematoma
0(0.0%)
Re‐bleeding 1(1.9%)
ContrastUsage(cc)
N47
Mean 66.1
StandardDeviation 42.14
Median 55.0
Minimum,Maximum 12,220


Table9:SummaryofAllAdverseEvents(Sub‐studySubjects)
SystemOrganClass
PreferredTerm
AllPRECISEStentSubjects
(N=52)
Number(%)ofSubjectswithoneormoreAdverseEvents 21(40.4%)
BloodAndLymphaticSystemDisorders2(3.8%)
Anaemia2(3.8%)
CardiacDisorders1(1.9%)
AtrialFibrillation1(1.9%)
CardiacFailureCongestive1(1.9%)
GastrointestinalDisorders6(11.5%)
Nausea5(9.6%)
Vomiting3(5.8%)
GeneralDisordersAndAdministrationSiteConditions 5(9.6%)
Pain5(9.6%)
InfectionsAndInfestations3(5.8%)
AdenoviralUpperRespiratoryInfection1(1.9%)
Infection1(1.9%)
UrinaryTractInfection1(1.9%)
Injury,PoisoningAndProceduralComplications 1(1.9%)
PostProceduralHaemorrhage1(1.9%)
Investigations3(5.8%)
BloodCreatinePhosphokinaseIncreased 1(1.9%)
OxygenSaturationDecreased1(1.9%)
TroponinIncreased1(1.9%)
MetabolismAndNutritionDisorders1(1.9%)
Hypomagnesaemia1(1.9%)
Hypophosphataemia1(1.9%)
NervousSystemDisorders4(7.7%)
CerebrovascularAccident1(1.9%)
Headache3(5.8%)
PsychiatricDisorders1(1.9%)
Hallucination,Visual1(1.9%)



Respiratory,ThoracicAndMediastinalDisorders 3(5.8%)
Atelectasis1(1.9%)
Rales1(1.9%)
Rhinorrhoea1(1.9%)
Wheezing1(1.9%)
VascularDisorders8(15.4%)
ArteryDissection1(1.9%)
Hypotension6(11.5%)
OrthostaticHypotension1(1.9%)


ThepatientdemographicsandresultsfromtheROADSTERsub‐studyincludingsubjectsreceivingthePRECISEstent
(N=52)werecomparablethoseoftheROADSTERpivotalstudycohort(N=141).

9.0DirectionsforUse
Onlyphysicianswhohavereceivedappropriatetrainingfortranscarotidstentingandwhoarefamiliarwiththe
principles,clinicalapplications,complications,sideeffectsandhazardscommonlyassociatedwithcarotid
interventionalproceduresshouldusethisdevice.

9.1Peri‐ProceduralCare
Table10
Pre‐ProcedureMedications
MedicationDoseTimepriorto
procedure
Notes
Aspirin75‐325mg*Atleast72hrs A650mgloadingdoseofaspirin,providedthatitisnot
entericcoatedorextendedrelease,atleast4hoursprior
toprocedureisacceptableif325mgdosingwasnot
administeredpriortoprocedureorpertheInstitution's
standardofcare.
Clopidogrel75mgAtleast72hrs A450mgclopidogrelloadingdoseatleast4hourspriorto
procedureisacceptableif75mgdosingwasnot
administeredpriortoprocedure.Thephysicianmay
substituteprasugrel,ticlopidine,oragenericversionof
clopidogrelperthemanufacturer'spublishedguidelines.
Ifticlopidineisprescribed,itmustbeadministeredwith
theappropriatesafetymonitoringattwoweeksandat
onemonth.
*Asstatedinthe"2011ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVSguidelineon
themanagementofpatientswithextracranialcarotidandvertebralarterydisease:executivesummary."and"ESVS
Guidelines.InvasiveTreatmentforCarotidStenosis:Indications,Techniques."












Table11
Post‐ProcedureMedications

MedicationDoseDurationpost‐
procedure
Notes
Aspirin75‐325mg*Daily,
continued
indefinitely
Aspirindosagemaybeadjustedatthediscretionofthe
Investigatorand/orifwarrantedbythepatient'smedical
condition,i.e.,documentedintolerance,GIbleed,etc.
Allchangeinmedicationsaretobedocumentedonthe
ConcomitantMedicationCRF.
Clopidogrel75mgDaily,
forminimumof4
weeks
Clopidogreldosingmayextendatphysician'sdiscretion.
Thephysicianmaysubstituteprasugrel,ticlopidine,ora
genericversionofclopidogrelperthemanufacturer's
publishedguidelines.
*Asstatedinthe"2011ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVSguidelineon
themanagementofpatientswithextracranialcarotidandvertebralarterydisease:executivesummary."and"ESVS
Guidelines.InvasiveTreatmentforCarotidStenosis:Indications,Techniques."
Inadditiontotheusualcareandthesuggestedperi‐procedurepharmacologicalregimen,specialattentionto
diagnosisandmanagementofthefollowingconditionsarecriticalforoptimalpatientcare:
•Bradycardiaortachycardia
•Hypertensionorhypotension
•Acuteandsubacutestentthrombosis
•Hyperfusionsyndrome


9.2Pre‐Procedure
RefertoSection9.1oftheseinstructionsforthesuggestedpre‐procedurepharmacologicaltreatmentregimen.
Theplacementofthestentinastenoticorobstructedcarotidarteryshouldbedoneinaprocedureroom
equippedwithangiography.Angiographyshouldbeperformedtomapouttheextentofthelesion(s)andthe
collateralflow.Ifthrombusispresent,donotproceedwithstentdeployment.Patientpreparationandsterile
precautionsshouldbethesameasforanyangioplastyprocedure.
CAUTION:Venousaccessshouldbeavailableduringcarotidstentinginordertomanagebradycardiaand/or
hypotensioneitherbypharmaceuticalinterventionorplacementofatemporarypacemakerifneeded.
CAUTION:Whencathetersareinthebody,theyshouldbemanipulatedonlyunderfluoroscopy.Radiographic
equipmentthatprovideshighqualityimagesisneeded.
a.Injectcontrastmedia–PerformanangiogramusingthetechniquedescribedintheENROUTETranscarotid
NPS'sInstructionsforUse.
b.Identifyandmarkthelesion–Fluoroscopicallyidentifyandmarkthelesion,observingthemostdistallevelof
thestenosis.

9.3DeviceSelectionandPreparation
1.SelectStentSize
Measurethelengthofthetargetlesiontodeterminethelengthofstent(s)required.Whenmorethanonestentis
requiredtocoverthelesion,themoredistalstentshouldbeplacedfirst.Overlapofsequentialstentsisnecessary,
buttheamountofoverlapshouldbekepttoaminimum(approximately5mm).

Measurethediameterofthereferencevessel(proximalanddistaltothelesion).Itisnecessarytoselectastent,
whichhasanunconstraineddiameterthatis1to2mmlargerthanthelargestreferencevesseldiameterto
achievesecureplacementaccordingtothefollowingStentSizeSelectionTable(Table12).



Table12
ENROUTETranscarotidStentSystem‐StentSizeSelectionTable

Vessel
Lumen
Diameter
(mm)
Unconstrained
Stent
Diameter
(mm)
%Length
Foreshortening*
(%)
3.0
–
4.05.0 1.2
4.0
–
5.06.0 2.4
5.0
–
6.07.0 4.1
6.0
–
7.08.0 6.2
7.0
–
8.09.0 5.8
8.0
–
9.010.0 8.0
   *Calculated
2.PreparationofStentDeliverySystem
CAUTION:TheENROUTETranscarotidStentSystemissuppliedSTERILEandisintendedforsingleuseonly.DONOT
resterilizeand/orreusethedevice.Assurethatthedevicehadbeenproperlystoredinacool,dark,dryplaceprior
touse.
CAUTION:UsetheENROUTETranscarotidStentSystempriortothe“UseBy”datespecifiedonthepackage.Do
notuseifthepouchisopenedordamaged.
CAUTION:TheENROUTETranscarotidStentSystemisshippedwiththeTuohyBorstvalveOPEN.Becarefulnotto
prematurelydeploythestentduringpreparation.Thesystemshouldbepreppedinthesteriletrayperthebelow
instructions.ClosetheTuohyBorstvalvepriortoremovingthedevicefromthetray.
a.Opentheouterboxtorevealthepouchcontainingthestentanddeliverysystem.
b.Checkthetemperatureexposureindicatoronthepouchtoconfirmthattheblackdottedpatternwithagray
backgroundisclearlyvisible.Donotuseifentiretemperatureexposureindicatoriscompletelyblackasthe
unconstrainedstentdiametermayhavebeencompromised.
c.Aftercarefulinspectionofthepouchlookingfordamagetothesterilebarrier,carefullypeelthepouchopenand
removethetray.Withoutremovingthedevicefromthetray,examinethedeviceforanydamage.Ifitissuspected
thatthesterilityorperformanceofthedevicehasbeencompromised,thedeviceshouldnotbeused.
d.Withthedeviceinthetray,attachastopcocktotheYconnectionontheTuohyBorstvalve.
e.(RefertoFig.2)Withthedevicestillinthetray,attacha5‐ccsyringefilledwithheparinizedsalinesolutiontothe
openedstopcockattachedtotheYconnection(9)ontheTuohyBorstvalve(1).EnsurethattheTuohyBorst
proximalendvalve(12)isintheopenposition.Applypositivepressuretothesyringeuntilsalineweepsfromthe
proximalendoftheTuohyBorstvalve(12).LocktheTuohyBorstvalve.
f.ClosethestopcockattachedtotheTuohyBorstYconnection.
g.Extractthestentdeliverysystemfromthetray.Examinethedeviceforanydamage.Evaluatethedistalendof
thecathetertoensurethatthestentiscontainedwithintheoutersheath.Donotuseifthestentispartially
deployed.Ifagapbetweenthecathetertipandoutersheathtipexists,opentheTuohyBorstvalveandgentlypull
theinnershaftinaproximaldirectionuntilthegapisclosed.LocktheTuohyBorstvalveaftertheadjustmentby
rotatingtheproximalvalveendinaclockwisedirection.

9.4StentDeploymentProcedure
WARNING:Ensurethatthecathetersystemisflushedaccordingtothestepsoutlinedin"IntroductionofStent
DeliverySystem".FailuretodosocouldresultinairenteringtheENROUTETranscarotidArterialSheath.
WARNING:EnsurethatthereisatightsealbetweentheENROUTETranscarotidStentSystemandthevalveforthe
ENROUTETranscarotidArterialSheathduringaspiration.FailuretodosocouldresultinairenteringtheENROUTE
TranscarotidArterialSheath.