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PATIENTGUIDE FOR TRYTONSIDEBRANCHSTENT ® Indications,contraindications,warningsandinstructionsforusecanbefoundinthelabeling suppliedwitheachproduct.CAUTION:Federal(U.S.A.)lawrestrictstheseproductstosaleby orontheorderofaphysician. TRYTONSideBranchStent®isaproductofTRYTONMedicalInc. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page 1 of 17 Patient Guide, TRYTON Side Branch Stent PATIENTINFORMATIONGUIDE.............................................................................................................................................3 CORONARYARTERYDISEASE(CAD)....................................................................................................................................4 WHATISCAD?....................................................................................................................................................................................................4 WHATARETHESYMPTOMSOFCAD?..............................................................................................................................................................4 TREATMENTOFCAD..........................................................................................................................................................................................5 CORONARYARTERYSTENTS..............................................................................................................................................................................6 TRYTONSIDEBRANCHSTENT®.............................................................................................................................................6 WHENTHETRYTONSTENTSHOULDNOTBEUSED(CONTRAINDICATIONS)........................................................7 POTENTIALADVERSEEVENTSASSOCIATEDWITHTHETRYTONSIDEBRANCHSTENT...................................8 THETRYTONCLINICALTRIALS.............................................................................................................................................9 YOURCORONARYSTENTPROCEDURE.............................................................................................................................10 HOWDOIPREPAREFORMYPROCEDURE?.................................................................................................................................................10 YOURTRYTONSIDEBRANCHSTENTPLACEMENTPROCEDURE.............................................................................10 IMMEDIATELYAFTERPROCEDURE.................................................................................................................................................................12 TAKEALLMEDICATIONSASINSTRUCTED....................................................................................................................................................12 FOLLOW-UPCARE.............................................................................................................................................................................................13 KEEPYOURPATIENTIMPLANTCARDHANDY.............................................................................................................................................13 MRIINFORMATION..........................................................................................................................................................................................13 FREQUENTLYASKEDQUESTIONS......................................................................................................................................14 GLOSSARY...................................................................................................................................................................................15 D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page2of17 Patient Guide, TRYTON Side Branch Stent PATIENTINFORMATIONGUIDE YouhaverecentlyhadaTRYTONSideBranchstentimplantedinthecoronaryarteriesof yourheart,oryouhavecoronaryarterydiseasethatmaybetreatedwithaTRYTONSide BranchStent.Thefollowinginformationisimportantforyoutoknow,includingthepossible risksassociatedwithhavingastentimplantalongwithmedicationrecommendationsand questionsyoumayhaveaboutyourstent. IfyouhaveanyquestionsabouttheTRYTONSideBranchStentorthestentingprocedure afteryoureadthisbooklet,besuretoaskyourphysician. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page3of17 Patient Guide, TRYTON Side Branch Stent CORONARYARTERYDISEASE(CAD) WhatisCAD? CADisthemostcommonformofheartdisease.Itisaconditionthatoccurswhenthe arteriesthatsupplyoxygen-richbloodandnutrientstotheheartmusclebecomenarrowed orblockedbyagradualbuild-upofplaque.Plaqueismadeupoffattydeposits(cholesterol), whitebloodcells,calcium,andothersubstancesthatcollectovertimeinthewallofa coronaryartery.Thisprocessiscalledatherosclerosis.Astheplaquenarrowstheopening (lumen)ofacoronaryartery,itcanlimitbloodflowtotheheartmuscle. Source: https://commons.wikimedia.org/wiki/File:Blausen_0257_CoronaryArtery_Plaque.png WhataretheSymptomsofCAD? TwocommonsymptomsofCADarechestpain(alsoknownasangina)andshortnessof breath,whicharecausedbythereductionofbloodflowtotheheartmuscle.Ifplaque build-updoesnotreducebloodflowexcessively,theremaybenosymptomsatrest,but symptomssuchaschestheavinessorpressuremayoccurwithexerciseorstress.Aheart attack(myocardialinfarction)canoccurifthearterysuddenlybecomescompletely blocked,usuallybyabloodclotthatformsoverruptured(broken)plaque.Heartattacks causepermanentdamagetotheheartmuscleandcanalsoleadtosuddendeath. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page4of17 Patient Guide, TRYTON Side Branch Stent CADsymptomsthatpatientsmayexperienceare: • Paininthejaworneck • Painradiatingtothearmsorback • Heartburn • Nausea • Vomiting • Heavysweating Whenbloodflowissignificantlyreduced,andtheheartmuscledoesnotreceiveenough bloodtomeetitsneeds,severesymptomssuchaschestpain(angina),heartattack (myocardialinfarction),orheartrhythmdisturbances(arrhythmias)mayoccur. TherearesomepatientswhoreportnosymptomsofCAD.Itispossibletohaveaheart attackwithoutexperiencinganysymptoms. RecentresearchhasshownthatsomewomenexperiencedifferentCADsymptomsfrom menandarelesslikelythanmentoreportchestpain,heavinessinthechest,orchest discomfortduringaheartattack.Womenmaynoticeotherearlysymptoms,suchas unusualtirednessorsleepdisturbancesuptoonemonthpriortoaheartattack.These differencesinsymptomsmaycausesomewomentodelayseekingtreatment. TreatmentofCAD CADcanbemanagedbyacombinationofchangesinlifestyle(eatingahealthydietthatis lowinsaturatedfat,regularexercise,andquittingsmoking)andmedicaltreatment.Your treatmentmayincludemedicationstorelieveyourchestpainand/ortoexpandthe coronaryarteries,increasingbloodflowtoyourheart.However,becausemedicinealone maynotadequatelyrelieveyoursymptoms,youmayneedfurthertreatments,whichmay includebypasssurgery,balloonangioplasty,andstenting.Yourphysicianhasdetermined thatuseofacoronarystentisthebesttreatmentforyou. Inabout15%ofpatients,theblockageinamajorheartarteryalsoinvolvesablockage withinasidebranchthatcomeoffofthatmajorheartartery.Thisisreferredtoasa bifurcationlesion.Bifurcationlesionsaremorecomplexthannon-bifurcationlesions,and theirtreatmentwithangioplastyandstentsisassociatedwithhigherrisksofheartattack andtheneedforarepeatproceduretotreatare-narrowedheartvessel. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page5of17 Patient Guide, TRYTON Side Branch Stent CoronaryArteryStents Coronaryarterystentsaredevices(smallmetallicmeshtubes)thatareplacedovera ballooncatheteranddeliveredtothenarrowedportionofacoronaryartery.Theballoonis usedtoexpandthestent.Thestentpressesagainstthenarrowedvesselwall,holdingthe vesselopen.Thismakesawiderchanneltoimprovebloodflowtotheheartmuscle.This maybefollowedbyrepeatballooninflationswithinthestenttoachievetheresultdesiredby yourdoctor.Oncetheballoonhasbeendeflatedandwithdrawn,thestentstaysinplace permanently,holdingthecoronaryarteryopen.Theinnerliningofthearterygrowsover thesurfaceofthestent,makingthestentapermanentpartofyourartery. Coronaryarterystentsarelessinvasivethanbypasssurgery.Stentinginvolvesashorter hospitalstay–usuallyonetothreedays–andfasterrecoverythansurgery.However,the coronaryarterymayre-narrow(calledrestenosis)insomepatientswhoreceivestents(instentrestenosis),duetothebuild-upofscartissuewithinthestentleadingtonarrowingof thestentlumen.Thismayrequirefurthertreatments,suchasrepeatangioplastyand/or bypasssurgery,toreopenthearteryandincreasebloodflowtotheheart. TRYTONSIDEBRANCHSTENT® TheTRYTONSideBranchStentisastentmadefromcobaltchromiumalloy.Cobalt chromiumisabiocompatiblemetalspecificallydevelopedforcoronarystents.Thestentis flexibleandwasspeciallydesignedtoallowittofittheshapeofablockedmajorheartartery thatalsohasablockageinasidebranch(bifurcationlesion).TheTRYTONSideBranchStent isdeliveredtothearteryonaballoondeliverycatheterandwillbeusedwithanother company’sdrug-elutingstent(DES)thatyourdoctorwillimplantinoneofyourmainheart arteries. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page6of17 Patient Guide, TRYTON Side Branch Stent DiagramoftheTRYTONSideBranchStentmountedon DeliveryBalloon Mid Markers Proximal Marker Distal Marker WHENTHETRYTONSTENTSHOULDNOTBEUSED(CONTRAINDICATIONS) • • • • • • • • • • • • • • • • Ifyourarteryiscompletelyblocked Ifyourphysicianseesmoderatetoseverecalciumdepositsintheartery Ifyourarteryisseverelycurvedmakingitdifficulttogettotheblockage Ifyourphysicianseesbloodclots/thrombusblockingtheartery Ifyourphysicianfeelshe/shecannotcompletelyinflatetheangioplastyballoon Notinflatingtheangioplastyballooninthemainbranchandsidebranchpriorto TRYTONstentplacement PlacementofTRYTONstentalone,withoutamainbranchstent PoorflowbeyondthestentimplantationsiteduetosevereCAD Anuntreatedsignificant(>50%)blockagebeforeorafterthemainbranchorside branchtargetlesion Ifyourheart’spumpingstrengthisverypoor Ifyouhaveimpairedkidneyfunction Ifyouhaveabnormalbloodtestsindicatingbleedingdisorders,increasedriskof infections,orknownorsuspectedliverdisease Ifyouarearecipientofhearttransplant Ifyouhaveanallergyorhypersensitivitytocobalt-chromiumorstructurallyrelatedcompounds,cobalt,chromium,nickel,ortungsten Ifyourphysicianplanstoperformrotationalatherectomy(useofadevicetobreak upplaqueinsidetheartery) Ifyourphysiciandecidesyoushouldnotreceiveadrug-elutingstentbecauseyou cannottaketherecommendedbloodthinninganti-plateletmedications D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page7of17 Patient Guide, TRYTON Side Branch Stent POTENTIALADVERSEEVENTSASSOCIATEDWITHTHETRYTONSIDEBRANCH STENT TherisksofusingtheTRYTONSideBranchStentaresimilartothosethatareassociated withotherstandardheartstentprocedures.Astentthatbecomesblockedbyabloodclot mayleadtoaheartattack,theneedforurgentbypasssurgery,deathortheneedfor anotherangioplastyprocedure.Evenwithsuccessfulstentimplants,thereisachanceofrenarrowing(restenosis)ofyourcoronaryartery.Thismayrequirefurthertreatments,such asrepeatangioplastyand/orbypasssurgery,toincreasebloodflowtotheheart.Therisks fromusingballooncatheterstoimplantstentsmaybeseriousenoughtorequiresurgeryor causedeath. Otherrisksassociatedwithballoonangioplastyandheartstentimplantationprocedures include,butarenotlimitedto: • Abruptvesselclosure(suddenclosureofthevessel) • Acutemyocardialinfarction(heartattack) • Aneurysm(weakeningofaportionofthewallofthebloodvessel) • Arrhythmia,includingventricularfibrillation(irregularheartbeat) • Arteriovenousfistulas(abnormalconnectionbetweentwovesselsthat normallydonotconnect • Coronaryarteryspasm • Coronaryvesseldissection(tearwithinthebloodvesselwall),perforation,or injury • Death • Drugreactionsorallergicreactionstocontrastmedium • Emboli(air,piecesofdevices,fragmentsofclot,orfragmentsofplaquethat canblockbloodvesselscausingtissueinjury) • Fever • Hematoma(tissueswellingcausedbyabloodclot)orhemorrhage(bleeding) • HypotensionorHypertension(decreasedorincreasedbloodpressure) • Hypersensitivity(allergic)reactions • Infection • Myocardialischemia/Angina,(chestpainduetodecreasedoxygensupplyto theheart) • Non-heart-relatedchestpain • Pseudoaneurysm(enlargementofabloodvesselduetoaninjurytotheblood vesselwall) • Restenosisofthetreatedvessel(re-blockageofthebloodvesselfollowingthe procedure) • Stentmisplacementormigration(movementofthestentfromwhereitwas placed) D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page8of17 Patient Guide, TRYTON Side Branch Stent • • • • Stroke Thrombosis(bloodclotwithinabloodvessel) Occlusion(blockage)ofacoronaryarteryorheartbypassgraft Anginapectoris(chestpaincausedbyinadequatebloodflowtotheheart) THETRYTONCLINICALTRIALS ThesafetyandeffectivenessoftheTRYTONSideBranchStentwasestablishedintwo researchstudies:theTRYTONPivotalRandomizedClinicalTrial(RCT)andtheExtended Access(EA)ConfirmatoryStudy. IntheTRYTONPivotalRCTStudy,704patientswithCADinvolvingbifurcationlesions wererandomlydividedintotwogroupsfortreatment.Onegroupof355patientswas assignedtoreceivetheTRYTONStenttotreattheblockedsidebranch,andtheother groupof349patientswastobetreatedwithballoonangioplastyoftheblockedside branch.Bothpatientgroupsalsoreceivedanapproveddrug-elutingstenttotreatthe blockageinthemajorvessel.At9monthsaftertheprocedure,patientsintheTRYTON grouphadahigherrateofheart-relatedcomplications(16.7%)comparedtothe balloon angioplastygroup(12.6%),butmostofthedifferenceinthecomplicationratebetween thetwogroupswasduetoverysmallheartattacksoccurringatthetimeofthe procedure.Importantly,whendoctorsusedtheTRYTONstentinsidebranchheart vesselsthatweresuitedtothesizerequirementsoftheTRYTONStent,therateofheartrelatedcomplicationsat9monthswaslowerintheTRYTONgroup(10.5%)versusthe balloonangioplastygroup(14.8%).Overall,implantationoftheTRYTONStentappears tobecomparabletoangioplastywithregardtoheart-relatedcomplications. ImplantationoftheTRYTONStentwasalsoassociatedwithareductionintheseverity ofsidebranchblockageat9monthscomparedtoballoonangioplasty. TheTRYTONExtendedAccess(EA)ConfirmatoryStudyincluded133patientswith heartvesselbifurcationlesionsimplantedwiththeTRYTONSideBranchStenttotreat theblockedsidebranchalongwithimplantationofanapproveddrug-elutingstentto treattheblockageinthemajorvessel.ThefocusoftheEAStudywasontherateofheart attacksassociatedwithimplantationoftheTRYTONStentinpatientswithheartvessel sidebranchesthatwereoftheappropriatesizefortreatmentwiththeTRYTONStent. TheEAstudyshowedthatdoctorscouldidentifysidebranchheartvesselsthatwere suitedtothesizerequirementsoftheTRYTONStent inover99%oftheenrolled patients.Therateofheartattacks(mostofwhichwereverysmall)associatedwith implantationoftheTRYTONStentmetthegoalestablishedfortheEAstudy. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page9of17 Patient Guide, TRYTON Side Branch Stent YOURCORONARYSTENTPROCEDURE HowDoIPrepareforMyProcedure? Inthedayspriortoyourtreatment,makesureyou: • Tellyourdoctoraboutallofyourmedications • Takeallofyourprescribedmedicines • Tellyourdoctorif,foranyreason,youcannottakeaspirinorotherbloodthinning drugssuchasPlavix,Effient,orBrilinta • Makesureyourdoctorknowsaboutanyallergiesyoumayhave • Refrainfromeatinganddrinkingaftermidnightonthenightbeforeyourprocedure • Followallinstructionsgiventoyoubyyourdoctorornurse YOURTRYTONSIDEBRANCHSTENTPLACEMENTPROCEDURE Youmaybegivenamildsedativetohelpyourelax,butyouwillnotbeputtosleep.There aretworeasonsforthis.Firstly,mostpeoplefindtheyexperiencelittletonodiscomfort fromtheprocedure.Secondly,yourdoctormayneedtoaskyoutotakeadeepbreathwhile X-raysarebeingtaken,toimprovethequalityofthepictures. Yourprocedurewillbeperformedinacardiaccatheterizationlaboratory(cathlab).You willlieonanX-raytable,andanX-raycamerawillmoveoveryourchestduringthe procedure.Thestaffwillmonitoryourheartbyattachingseveralsmallpatchestoyour chestandusingaspecializedmonitor. Thebloodvesselatthetopofyourthighisthemostcommonsiteforcatheterinsertionand requiresaverysmallskinincision.Theareawillbeshavedandcleanedwithanantiseptic, andyouwillbegivenalocalanesthetictonumbthearea.Thisincisionwillallowan introducersheath(shorttube)tobeinsertedintoyourfemoralartery(themainarteryof thethigh,supplyingbloodtotheleg).Yourdoctorwilltheninsertaguidingcatheter(along flexibletube)intotheintroducersheathandadvanceittowherethecoronaryarteries branchofftotheheart.Aflexibleguidewireisthenadvancedthroughtheguidingcatheter tothenarrowinginthecoronaryartery.Thishelpscarryallthenecessarydevicesrequired duringthestentingprocedure. Additionaloptionsforcatheterinsertionincludeanarmartery(brachialartery)ontheinside ofyourelbowandthewrist(radialartery). Afterthecathetersareadvancedtoyourheart,yourdoctorwillinjectfluid(contrastdye) throughtheguidingcatheterintoyourarterytoviewthenarrowing.Yourdoctorwillwatch theinjectiononanX-raymonitor,muchlikeaTVscreen.WhiletheseX-raysarebeing taken,yourdoctormayaskyoutotakeadeepbreathandholditforafewseconds.Youmay D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page10of17 Patient Guide, TRYTON Side Branch Stent alsobeaskedtocoughaftertheX-raypictureiscompleted,tohelpspeedtheremovalofthe contrastdyefromthearteries. Usingtheguidingcatheter,aballooncatheterwillbepositionedinthenarrowinginthe coronaryarteryandtheballoonistheninflated.Thiscompressestheplaqueandwidens thecoronaryarteryopening.Thisprocedureiscalledpre-dilatation.Theplacementofthe TRYTONstentisdescribedinthefollowingsteps: Step1:Thestentmountedonaballoon catheterisdeliveredtothenarrowinginthe SideBranchofthecoronaryarterybya deliverycatheter. Theballoonistheninflatedandthisexpands thestent,pressingitagainstthecoronary arterywall.Yourdoctormaychoosetoexpand thestentfurther,byusinganotherballoonso thatthestentcanmakebettercontactwiththe arterywall.Thisisknownaspost-dilatation. Step2: OncetheTRYTONSideBranchStentisinplace, adrug-elutingstentwillbeplacedintothe MainBranchofthearteryfollowingthesame procedure. Step3:Whenbothstentsareintheirpositions yourphysicianwillexpandbothstentsfurther byusingaballoonintheSidebranchand anotherballoonintheMainbranch.Both stentsremainasapermanentimplantinyour coronaryartery. SelectingthesizeoftheTRYTONSideBranch Stentthatcorrectlymatchesthearterysizeis veryimportanttoobtainthebestresultsfrom thestentingprocedure.Yourdoctormay choosetoperformadditionalmeasurementsof thearterysizeusinganultrasoundcatheterbeforeorafterplacingthestents. Theimplantationprocedureofthestentsusuallylastsabout90minutes,duringwhichtime yourdoctorwillaskyoutoremainverystill.Forthemostpart,youwillbecomfortable,but youmayfeelsomepressureorchestpainwheneveraballoonisinflated.Thisisnormaland willquicklyfadewhentheballoonisdeflated. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page11of17 Patient Guide, TRYTON Side Branch Stent ImmediatelyafterProcedure Youwillbeaskedtolieflatforfourtosixhoursfollowingtheprocedureandtonotbend yourlegorarm,dependingonwhichareayourdoctorusedtoinsertthecatheters. Pressurewillalsobeplacedonthearea. Avascularclosuredevicemaybeusedtosealtheincisionsiteinyourgroinorarm.Youwill beallowedtogetupandwalkaroundsoonerifthistypeofdeviceisused. TakeAllMedicationsasInstructed Afteryouleavethehospital,yourcardiologistwillinstructyoutotakeadailydoseof aspirinandanotherbloodthinningantiplateletdrugsuchasPlavix,Effient,orBrilinta. Yourdoctorwilltellyouhowlongyoushouldcontinuetakingtheantiplateletdrugs.Itis veryimportantthatyoutakethesemedicationsexactlyasyourdoctorinstructsyou: • Follow your medication schedule exactly to avoid possible complications after youreceiveyourstent.Donotmissanydoses. Callyourdoctorifyoucannotkeeptakingyourmedicationsbecauseofsideeffectssuchas rash,bleeding,orupsetstomach. CAUTION:Donotstoptakingyourprescribedmedicationsunlessyouare instructedtodosobythedoctorwhoperformedyourstentprocedure. CAUTION:Notifyyourdoctorifyouarescheduledtoseethedentistwhileonantiplatelet medication.Yourdoctormayprescribeantibioticstoavoidthepotentialofaninfection. Youshouldreviewwithyourdoctoranyrecommendationsfromyourdentistoranyother healthcareprovidertostopyourprescribedmedications. Ifsurgeryordentalworkthatwouldrequireyoutostoptakingantiplateletmedicationsis recommendedafteryouhavereceivedthestent,youandyourdoctorsshouldcarefully considertherisksandbenefitsofthissurgeryordentalworkversusthepossiblerisks fromearlydiscontinuationofthesemedications. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page12of17 Patient Guide, TRYTON Side Branch Stent CAUTION:Beforeundergoingimplantationofadrug-elutingstent,speakwithyourdoctorif youplantohaveanytypeofsurgerythatmayrequireyoutostoptakingantiplatelet medications. Ifyoudorequirediscontinuationofantiplateletmedicationsbecauseofsignificantbleeding, yourcardiologistwillcarefullymonitoryouforpossiblecomplications.Onceyourcondition hasstabilized,yourcardiologistmayrestartthesemedications. Follow-upCare Youwillbedischargedtothecareofyourcardiologistorfamilydoctor.Youshouldbe abletoreturntoyournormalactivitiessoon. Yourdoctorwillaskyoutoreturnforfollow-upvisits.Thefirstvisitisusuallytwotofour weeksafteryourstentsareimplanted,withfollow-upvisitseverysixmonthsforthefirst year.Besuretokeepallappointmentsforfollow-upcare,includingbloodtests. CAUTION:Notifyyourdoctorimmediatelyifyouexperiencechestpain(angina),or noticeanychangessuchasmoresevereorfrequentchestdiscomfort,especiallyinthe firstmonthafteraprocedure.Thesesymptomsmayindicateare-narrowinginyour coronaryarteries. CAUTION:ShowyourPatientImplantCardifyoureporttoanemergencyroom.This cardidentifiesyouasapatientwhohashadastentimplanted. KeepYourPatientImplantCardHandy MRIInformation Ifyourequireamagneticresonanceimaging(MRI)scan,tellyourdoctororMRI technicianthatyouhaveastentimplant.MRImaybeperformedimmediatelyfollowing theimplantationoftheTRYTONstent(s).YourPatientImplantCardhasdetailed informationregardingthesafestMRIconditionstobeusedafterimplantationofthe TRYTONSideBranchStent. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page13of17 Patient Guide, TRYTON Side Branch Stent FREQUENTLYASKEDQUESTIONS Howlongwillthestentstayinmybody?Stentsaredesignedtostayinyourbody permanently. WillIbeabletofeelthestentinsideme?No,youwillnotbeabletofeelthestentonceit hasbeenimplantedinyourartery. Canthestentmoveorrust?Oncethestentispressedagainsttheinsidewallofyour coronaryartery,itwillremaininplacepermanentlyandwillnotmoveonitsown.Tissue willgrowaroundthestentandholditinplace.Itwillnotrustbecauseitismadeofnoncorrodingmetal. Willmystentsetoffthemetaldetectoratairportsecuritycheckpoints?No,yourstent implantwillnottriggeralarmsatsecuritycheckpoints. HowlongshouldItakemymedications?Themostimportantthingthatyoucandoto minimizetheriskofbloodclotswithinstents(stentthrombosisis)totakethebloodthinning antiplateletmedicationsyourdoctorprescribes.Donotstoptakingthesemedicinesuntil yourcardiologisttellsyouto,evenifyouarefeelingbetter. WhatifIstillgetpains?Ifyouexperiencepain,informyourcardiologistorthecenter wheretheprocedurewasperformedimmediately. WhataretherestrictionsorcautionsafterI’vereceivedastent?Ifyourequiremagnetic resonanceimaging(MRI),tellyourdoctororMRItechnicianthatyouhaveanimplanted stent. WhencanIresumemyregularactivities?Yourdoctorwilladviseyou.Manypatientscan returntoworkandfollowtheirnormalroutineaboutaweekaftertheirstentprocedure. WhatshouldIchangeinmydiet?Yourdoctormayprescribeacardiacdiettohelpreduce thelevelsoffatinyourbloodandreduceyourrisk. CouldIhaverecurringsymptoms?Yes,itispossiblethatyouwillexperiencesymptoms again,eitherduetoanewblockageintheregiontreatedwiththestentorduetoablockage atanotherplaceinyourcoronaryarteries.Yourdoctorwillmonitoryourprogress. HowcanIhelppreventarecurrenceofsymptoms?Whilethereisnosurewaytoprevent arecurrenceofsymptoms,youcanreducetheriskthroughexercise,notsmoking,eatinga healthydiet,andtakingrecommendedheartmedications.Yourdoctorcanadviseyouabout lifestylechanges. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page14of17 Patient Guide, TRYTON Side Branch Stent GLOSSARY Angina:Chestpaincausedbyaninadequatesupplyofbloodtotheheart. Angioplasty(alsoreferredtoasPTCA):Aminimallyinvasiveprocedureinwhicha ballooncatheterispassedthroughtotheblockedareaofanartery.Onceinflated,the ballooncompressestheplaqueagainstthebloodvesselwallandenlargesthevessel opening.Anangioplastycanalsobeperformedwithplacementofastent. Anticoagulant:Amedicationtopreventorslowtheclottingofblood. Antiplatelet:Asubstancetoreduceclumpingofplateletsintheblood.Anantiplatelet medicinehelpsthinthebloodtopreventclotformation. Atherosclerosis:Adiseasethatcausesnarrowingorblockageofarteriescausedbya build-upoffat(cholesterol)withinthearterywall.Thebuild-upisreferredtoasplaque. Bifurcationlesion:Amajorcoronaryarterywithblockagethatalsohasablockageina sidebranch. CardiacCatheterizationLaboratory(CathLab):AsterileX-raytheaterinwhichheart catheterizationisperformed. Catheter:Athin,hollow,flexibletubeusedtoaccessthecoronaryarteriesduringan angiogramorduringanangioplastyprocedure.Thiscathetercanbeusedtoinject medication,fluids,orcontrastdyeduringtheprocedure.Acathetercanalsorefertothe deviceusedtodelivertheballoonorstentduringanangioplastyprocedure. CoronaryAngiography(orHeartCatheterizationorCardiacCath):Atestinwhich contrastdyeisinjectedtocreateimagesofthecoronaryarteries.Thisallowsthedoctorto seetheextentofthediseaseinthecoronaryarteriesandmakeadecisiononhowtobest treattheblockages. CoronaryArteries:Thebloodvesselsthatcarrybloodcontainingoxygentotheheart muscle.Therearefourmajorcoronaryarteries:theleftmain,therightcoronaryartery,the leftanteriordescending,andtheleftcircumflex. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page15of17 Patient Guide, TRYTON Side Branch Stent CoronaryArteryBypassGraftSurgery(CABG):Open-heartsurgerytotreatCAD. CoronaryArteryDisease(CAD):Theformationofblockagesoratheroscleroticplaques withincoronaryarteriesthatresultinrestrictedbloodflowtotheheartmuscle. EmboliorEmbolism:Air,piecesofdevices,orfragmentsofbloodclotsthattravelinthe bloodstreamandblockthebloodvessel Electrocardiogram(ECG/EKG):Atestthatrecordstheelectricalactivityoftheheart.An ECG/EKGmayindicatethatpartsoftheheartmusclearedamagedduetodecreasedblood flow. FemoralArtery:Themainarteryofthethighthatsuppliesbloodtothelegandisoftenused toinsertcatheterstoperformcoronaryangiographyprocedures. In-stentRestenosis:Recurrentblockageornarrowingofapreviouslystentedvessel. LocalAnesthetic:Asubstanceusedtonumbtheareatowhichitisapplied. Lumen:Theinnerchannelorcavityofavesselortube.Inabloodvessel,itisthe openingthroughwhichbloodflows. MyocardialInfarction(MI):Aheartattack,whichisduetointerruptioninthebloodflow totheheartmuscleandresultsindamageofanareaofhearttissue. MagneticResonanceImaging(MRI):Anon-invasiveprocedureusedtoobtainimagesof internalbodystructuresthroughtheuseofmagnetsandradiowaves. Percutaneous:Performedthroughtheskin. Plaque:Anaccumulationorbuild-upoffattydeposits,calcium,whitebloodcells,and scartissueinthewallofanarterythatresultsinnarrowingofthevessellumen. Restenosis:Arecurringblockagecausedbytheexcessivegrowthofscartissueinsidethe arteryorstentthatmayoccurfollowinganangioplastyprocedure. D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page16of17 Patient Guide, TRYTON Side Branch Stent Stent:Ametallicmeshtubethatisimplantedintoanarteryduringanangioplasty, providingascaffoldtohelpholdthearteryopenandincreasingbloodflowtotheheart muscle. TRYTONSideBranchStent/StentDeliverySystem®isregisteredtrademarksofTRYTON MedicalInc. PlavixisaregisteredtrademarkofSanofi-AventisCorporation. EffientisaregisteredtrademarkofEliLillyandCompany. BrilintaisaregisteredtrademarkoftheAstraZenecagroupofcompanies. Formoreinformation,visitourwebsiteatwww.trytonmedical.com Allrightsreserved. Note:Third-partytrademarksareregisteredtrademarksoftheirrespectiveowners. Thisproductisintendedforusebyorunderthedirectionofa physician.Itisimportanttoreadthoroughlytheinstructions foruse,warnings,andpotentialcomplicationsassociatedwith theuseofthisdevice. 1000 Park 40 Plaza Suite 325 Durham, NC 27713, USA Phone: +1.919.226.1490 Fax: +1.919.226.1497 www.trytonmedical.com D1302USG_V01 PrintJobLotNumber:D1302USG_V01-DDMMYYYY Page17of17