gelsoft plus gelseal gelweave vascular prostheses...the prosthesis must be immersed in a sterile...

Gelsoft™

Gelsoft™ PlusGelseal™

Gelweave™ Vascular Prostheses

Instructions for Use

English Instructions for Use ………................................. x

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English

Vascutek Ltd. Gelsoft™, Gelsoft™ Plus, Gelseal™ & Gelweave™ Vascular Prostheses

Instructions for Use

CONTENTS

SECTION 1 INSTRUCTIONS FOR USE

1.1 Description1.2 Indications for Use1.3 Contraindications1.4 Warnings & Precautions1.5 Patient Counselling and Adverse Events1.6 Additional Instructions1.7 MagneticResonanceImaging(MRI)Safety

SECTION 2 ADDITIONAL INFORMATION

2.1 Origin of Gelatin2.2 Sterilisation2.3 Packaging2.4 Storage Conditions2.5 AdditionalLabels2.6 Returning a Prosthesis 2.7 Disposal of Prostheses

SECTION 3 CLINICAL EVIDENCE AND REFERENCES

SECTION 4 EXPLANATION OF SYMBOLS ON PRODUCT LABELLING

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SECTION 1 INSTRUCTIONS FOR USE

SECTION 1.1 DESCRIPTION

Gelsoft™, Gelsoft™ Plus & Gelseal™vascularprosthesesaregelatinsealedwarpknittedpolyesterprostheses,designedforsystemicvascularrepair.

Gelweave™vascularprosthesesaregelatinsealedwovenpolyesterprostheses,designedforsystemicvascularrepair.

Branched versions of the Gelseal™ and Gelweave™ vascular prostheses accommodate reconstruction of the associated side vessels and allow intra-operative attachment to cardiopulmonary bypass. The presence ofradiopaque markers (Gelweave™prosthesesonly)aidsin vivo visualisation.

SECTION 1.2 INDICATIONS FOR USE

Knitted Vascular Prostheses

INDICATIONS FOR USE(CE Approved)

GelsealTM Vascular Prostheses

Systemicvascularrepairi.e.replacementorbypassproceduresinaneurysmal&occlusivediseaseofthearteries.

GelsealTM Ante-FloTM Vascular Prostheses

Ante-FloTM is indicated for replacement of the thoracic aorta due to aneurysmaland/oratheroscleroticarterialdisease.

GelsealTM Extra Anatomical Vascular Prostheses

Systemicvascularrepairi.e.primarilyforaxillo-femoral/bi-femoralbypass& femoral popliteal reconstruction.

GelsealTM Branched Vascular Prostheses


GelsoftTM Vascular Prostheses


GelsoftTM Extra Anatomical Vascular Prostheses


GelsoftTM Plus Vascular Prostheses


GelsoftTM Plus Extra Anatomical Vascular Prostheses


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Woven Vascular Prostheses

Please note: Product availability is subject to local regulatory approval.

SECTION 1.3 CONTRAINDICATIONS

Gelsoft™, Gelsoft™ Plus, Gelseal™ & Gelweave™prosthesesshouldnotbeimplantedinpatientswithactiveinfectionorwhoexhibitsensitivitytopolyester,tantalum(applicabletoGelweave™prosthesesonly),ormaterialsofbovineorigin.

Gelsoft™, Gelsoft™ Plus, Gelseal™ & Gelweave™ prostheses are contraindicated for coronary vascularrepair,bloodaccessfistula(e.g.haemodialysis)andpulmonaryshunting.

Gelsoft™ & Gelsoft™ Plus prostheses are contraindicated for thoracic use.

Gelsoft™, Gelsoft™ Plus, Gelseal™ & Gelweave™ prostheses are contraindicated for use in the extra-anatomic (EXCEPT for Gelsoft™/Gelsoft Plus™/Gelseal™ Ax-Fem and Ax-Bifem vascular prostheses*),pulmonarypositions,useinarteriovenousshuntingorcardiovascularpatching.

*AvailabilityofGelsoft™, Gelsoft™ Plus, Gelseal™ Ax-Fem and Ax-Bifem vascularprosthesesissubjecttolocalregulatoryapproval.

INDICATIONS FOR USE(CE Approved)

GelweaveTM Straight Vascular Prostheses


GelweaveTM Ante-FloTM Vascular Prostheses


Ante-FloTMis indicated for replacement of the thoracic aorta due to aneurysmaland/oratheroscleroticarterialdisease.

GelweaveTM Bifurcate Vascular Prostheses


GelweaveTM Branched Vascular Prostheses with or without radiopaque markers


Plexusvascularprosthesesarealsoindicatedforthereplacementoftheaorticarch&itsmajorbranchesi.e.thebraciocephalictrunk,commoncarotidarteryandsubclavianartery.

GelweaveTM Collared Ante-FloTM& Plexus Vascular Prostheses (with&withoutradiopaque markers)


Collared/SienavascularprosthesesarealsoindicatedforuseduringthefirststageofopenrepairofaorticarchaneurysmsusingtheElephant Trunk Technique.

GelweaveTM Valsalva Vascular Prostheses


GelweaveTM Valsalva is indicated for repair or replacement of damaged & diseasedthoracicaortaincasesofaneurysm,dissectionorcoarctation.

GelweaveTM Branched Vascular Prostheses, including Siena Vascular Prostheses

GelweaveTMbranchedvasularprostheses,includingSienavasularprosthesescanalsobeusedfordebranching,i.e.reconstructionoftheaorticvessels&associatedHybridprocedures.Hybridproceduresaredefinedasatreatmentcombinationemployingopensurgicaldebranchingwithendovasularaorticrepair.Hybrid&debranchingindicationsubjecttolocalregulatoryapproval.

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SECTION 1.4 WARNINGS & PRECAUTIONS

1. The Gelweave™vascularprosthesismaterialisbasedonawovenstructureandthereforemustbecutwithacauterytominimisefraying.NOTE: IMMERSION OF THE PROSTHESIS IN A STERILE SALINE SOLUTIONIMMEDIATELY PRIOR TO USE WILL PREVENT FOCAL BURNING WHICH MAY RESULT DURINGCAUTERISATION. THIS IS NOT REQUIRED IF ALREADY RINSED IN RIFAMPICIN AND / OR HEPARIN. The prosthesismustbeimmersedinasterilesalinesolutionfor5minutes.Failuretorinsefor5minutescouldleadtothegraftbeingmoresusceptibletoleakagewhenimplanted.Vascutekdonotrecommendthatthedeviceissoakedforlongerthan5minutesastheonsetofgelatinhydrolysismaystarttooccurwhichmayhaveanimpactonclinicalperformance.Theprosthesismustnotbeallowedtodryoutaftersoaking.2. ADDITIONAL CAUTION FOR ALL KNITTED PRODUCTS. USE OF A CAUTERY FOR ANY SEALEDPOLYESTER PROSTHESES CAN CAUSE BURNING. THIS CAN BE PREVENTED BY SOAKING IN STERILE SALINE, RIFAMPICIN AND/OR HEPARIN. The prosthesis must be immersed in a sterile saline solutionfor 5minutes.Failure to rinse for 5minutes could lead to thegraft beingmore susceptible to leakagewhenimplanted. Vascutek do not recommend that the device is soaked for longer than 5 minutes as the onset of gelatin hydrolysismaystart tooccurwhichmayhavean impactonclinicalperformance.Theprosthesismustnotbeallowedtodryoutaftersoaking.3. DO NOT PRECLOT.Theseprosthesescontainagelatinsealantandmustnotbepre-clotted.4. DO NOT USE BEYOND THE INDICATED EXPIRATION DATE.Thegelatinimpregnationmaynotmeetthedesignspecificationaftertheexpirationdate.5. DO NOT RESTERILISE. FOR SINGLE USE ONLY.Donotreuse,reprocessorre-sterilise.Reuse,reprocessingorresterilisationmaycompromisethestructuralintegrityoftheprosthesisand/orleadtoprosthesisfailurewhich,inturn,mayresultindeteriorationofhealthordeathofpatients.Reuse,reprocessingorresterilisationmayalsocreateariskofcontaminationoftheprosthesisand/orcausepatientinfectionorcrossinfection,includingbutnotlimited to the transmission of infectious disease(s) from one patient to another. Contamination of the prosthesismayleadtoinjury,illnessordeathofthepatientend-user.6. Theprosthesismustbeimplantedwithinonemonthafterremovalfromthefoilpouch.PleaserefertoSection2.3 Packaging.7.Clampingmaydamagetheprosthesis.Atraumaticclamps,ideallywithsoftshodjaws,shouldbeusedwithaminimumapplicationofforce.Excessiveforceshouldbeavoidedasitwilldamagethepolyesterfibresandthegelatin impregnation.8.Excessivetensionontheprosthesisshouldbeavoided.9.Roundbodytaperpointneedlesshouldbeusedwhenimplantingtheprosthesistominimisefibredamage.10. If de-airing is required then thesmallestneedlepossibleshouldbeused.A19gaugeneedle isnormallysufficient.Hypodermic needles havea cutting pointwhichmay result in blood leakageand require repair bysuturing.11. Caution should be exercised when performing the Elephant Trunk procedure.Although there has beensuccesswiththisprocedure,therehavebeenafewreportsofbleedingfromtheimplantedprosthesisduringthesecondstage.Variabilityofthepatient’shealingresponsemayaccountforthedifference.12. Additional caution for Gelweave™ Valsalva. For Valve sparing techniques ensure that the top of thecommissuresaresuturedtothenewsinotubularjunction(joinoftheprosthesisbodytotheskirt).13. Additional caution for Gelweave™ Siena collared prostheses.Prosthesissealant reabsorptionwillbecompletewithinapproximately14daysofthestage1openprocedure.Ifasecondstageconventionalopenrepairtechniqueisused,carefulhandlingandclampingofthedistalportionofthearchprosthesisshouldbeobservedinordertominimisebleedingthroughthissectionoftheprosthesiswall.14. Additional caution for Hybrid procedure.VascutekLtd.onlyrecommendstheuseofthe8mmand10mmsidebranchforthedebranchingandassociatedhybridprocedures.Ensurethattheprosthesissidebranchhasasuitableinsidediametertoaccommodatetheendovascularsystemchosen,ie.a20For22Fcathetershouldbeusedforan8mmsidebranchanda20F,22F24For26Fcathetershouldbeusedfora10mmsidebranch.**15. Themanufacturingprocessforgelatinsealedvasculargraftsusesthecross-linkingagentformaldehydetoachievethegraftperformance.AllgelatinsealedgraftsarethoroughlyrinsedwithROwatertoreduceresidualformaldehyde,howeverresidualamountsmaybepresentinthefinishedgraft.Formaldehydeisalsofoundatlowlevelsnaturallyinthebody,someofwhichisderivedfromfood.Formaldehydeisknowntobemutagenicandcarcinogenic.Therisksofthesepotentialharmsfromtheproducthavenotbeenestablishedclinically.16.Althoughtheseprosthesesaregelatinsealed,intraoperativeleakageatthebranchseamsmightoccasionallybeobserved.

**Hybridanddebranchingindicationsubjecttolocalregulatoryapproval.

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Arterialorvenousthrombosis Fever&localisedinflammation

Arteriovenousfistula Allergicreactiontopolyester/gelatin

Stenosis Oedema

Vascular spasm or vascular trauma Multi organ failure

Vessel damage Death

Anuerysminfection NeointamalHyperplasia

Prosthesis occlusion Prosthesis dilatation

Seroma Hepatic failure

Infectionoftheprosthesis/woundsite Lymphaticcomplicationse.g.lymphfistula

Aortic damage, including perforation, dissection,bleeding,rupture&death

Renal complications e.g. renal dysfunction, arteryocclusion,failure,infarction

Bleeding, blood loss, haematoma, coagulopathy,re-opening

Bowelcomplicationse.g. ileus,perforation, transientischaemia,infarction,necrosis

Aneurysmenlargement,rupture,death Wound complications e.g. dehiscence, infection,haematoma,seroma,cellulitis,pain

Genitourinarycomplicationse.g. ischaemia,erosion,fistula,incontinence,haematuria,infection,impotence

Cardiac complications e.g. arrhythmia, myocardialinfarction, congestive heart failure, hypotension,hypertension

Respiratorycomplicationse.g.pneumonia,respiratoryfailure,prolongedintubation,pulmonaryoedema

Neurological local or systematic complicationse.g. confusion, stroke, transient ischaemia attack,paraplegia,paraparesis,paralysis

Pseudoaneurysm

SECTION 1.5 PATIENT COUNSELLING AND ADVERSE EVENTS

PATIENT COUNSELLINGTheclinicianshould reviewallassociated risksandbenefitswhencounselling thepatientabout thisvascularprosthesis and all associated procedures.VascutekLtd.recommendsthattheclinicianinformthepatientofallassociatedrisksandbenefits,inwrittenform.Theseincludebutarenotlimitedto:• patientageandlifeexpectancy• risksandbenefitsrelatedtoprocedure• risksrelatedtonon-interventionaltreatmentormedicalmanagement• long term monitoring requirementsDetails regarding risks occurring during or after implantation of the device are provided in the Potential Adverse Events section.Pleaseinstructthepatientastoproperpostoperativecare,includinglimitingmovementoftheaffectedareaduringthe convalescent period.

POTENTIAL ADVERSE EVENTSAdverseeventsthatmayoccurand/orrequireinterventioninclude,butarenotlimitedto:

DEVICE RELATED ADVERSE EVENT REPORTINGAny adverse event involving aGelsoft™, Gelsoft™ Plus, Gelseal™, or Gelweave™ prosthesis should beimmediatelyreportedtoVascutekLtd.usingeithertheemailaddresscomplaints@vascutek.comorviayourlocaldistributor.

SECTION 1.6 ADDITIONAL INSTRUCTIONS

Gelsoft™, Gelsoft™ Plus, Gelseal™ & Gelweave™ prosthesesshouldbe immersedcompletely inasterilesalinesolutionfor5minutes.Theprosthesismustnotbeallowedtodryoutaftersoaking.Note:ThisisnotrequiredforprosthesesrinsedinRifampicinand/orHeparin.

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Stage 1Stage 2

Stage 3 Stage 4 Stage 5

Fillsyringeto 40ml

withsterilesolution.

Reconstitute 600mg of

Rifampicinwiththe 10ml of

diluent provided.

Drawupthe10mlofRifampicin solution

from (2) into the 50mlsyringetogive

a total volume of 50ml.

InjecttheRifampicin/saline solution through theTyveklidoftheblistercontainingthe

graft. Taking care not to damage the graft. Rock theblistertoensure

complete coverage of the graft.

After5minutes,thegraftcanberemoved-excesssolutionisallowedtodrainbeforethegraft is implanted.

Rifampicin Bonding (Optional Procedure) Standardoperatingroompractiseshouldbefollowedthroughoutthisproceduretoensurethatthesterilityofthe

graft,andofanyotheriteminvolved,isnotcompromised.

After5minutes,thegraftcanberemoved-excesssolutionisallowedtodrainbeforethegraft is implanted.

InjecttheHeparinsolutionthroughtheTyveklidoftheblistercontainingthegraft.Rocktheblistertoensurecomplete coverage of the

graft.

Fillsyringeto50mlwith

saline.

Drawup20,000units of Heparin

into a 50ml syringe.

Heparin Loading of Gelatin Sealed ProsthesesStandardoperatingroompractiseshouldbefollowedthroughoutthisproceduretoensurethatthesterilityofthe

graft,andofanyotheritemsinvolved,isnotcompromised.Stage 1 Stage 2 Stage 3 Stage 4

Additional Instructions for the Plexus and Ante-FloTM ProsthesesInitiation of Antegrade Perfusion:ThebypasscathetershouldbeplacedinthesidearmoftheAnte-FloTM and 4-BranchPlexusandsecurelyattached.

Completion of Antegrade Perfusion: Once bypass is complete, the cannula side arm of theAnte-FloTM and 4-BranchPlexusshouldbecutoffandtheremainingstumpover-sewnusingstandardsurgicaltechnique.

Additional Instructions for the Gelweave™ Valsalva prosthesis.ThecoronaryarteriesshouldbeanastomosedtotheskirtedsectionoftheGelweave™Valsalva™prosthesis.Theproximalcollarcanbeusedforprostheticvalve attachment or trimmed/inverted in valve sparing procedures according to the surgeon’s preference ofsurgical technique.

Gelsoft™, Gelsoft™ Plus, Gelseal™ & Gelweave™VascularprosthesesmaybeusedwithHeparinand/ortheantibioticRifampicin.Pleaserefertotheloadinginstructionsfortheseoptionalproceduresbelow.***

***Please Note: The Rifampicin/Heparin loading procedure is subject to local regulatory approval and has not been approved in the United States of America, Canada or Singapore.2

Pleasealsoconsidertheneedforintraoperativeandpostoperativepatientanticoagulationtherapy.

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Pulse Sequence T1-SE T1-SE GRE GRE

Signal Void Size 15,828mm2 1,424mm2 19,077mm2 2,012mm2

Plane Orientation Parallel Perpendicular Parrallel Perpendicular

SECTION 1.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY

Gelsoft™, Gelsoft™ Plus, Gelseal™ & Gelweave™ VascularProstheseswithoutradiopaquemarkersdonotcontainanymagneticormetalliccomponentsandarethereforeconsideredMRICompatible,althoughnoformaltestinghasbeencarriedoutontheseprostheses.

Gelweave™vascularprostheseswithradiopaquemarkersweredeterminedtobeMagnetic Resonance (MR)-conditional. Non-clinical testing determined that prostheses with radiopaque markers were MR conditional.Apatientwith thisprosthesiscanbescannedsafely, immediatelyafterplacementof theprosthesisunder thefollowingconditions:

Static Magnetic Field-Staticmagneticfieldof3Teslaorless.-Maximumspatialgradientmagneticfieldof720Gauss/cmorless.

MAGNETIC RESONANCE IMAGING (MRI) RELATED HEATINGIn non-clinical testing, prostheses with radiopaquemarkers produced the following temperature rises duringMagneticResonanceImagingperformedfor15minutesofscanning(perpulsesequence)in1.5Tesla/64MHz(Magnetom,SiemensMedicalSolutions,MalvernPA. SoftwareNumaris/4,VersionSyngoMR2002BDHHSActive-shielded,horizontalfieldscanner)and3Tesla(3Tesla/128MHz,Excite,HDx,Software14X.M5,GeneralElectricHealthcare,Milwaukee,WI)MRsystems:

1.5 Tesla 3 TeslaMRsystemreported,wholebody 2.9W/kg 2.9W/kgaveraged SAR .Calorimetrymeasuredvalues,wholebody 2.1W/kg 2.7W/kgaveraged SARHighest temperature change +1.7°C +2.0°C

Thesetemperaturechangeswillnotposeahazardtoahumansubjectundertheconditionsindicatedabove.

Artefact InformationMRimagequalitymaybecompromisediftheareaofinterestisintheexactsameareaorclosetothepositionoftheprosthesiswithradiopaquemarkers.Therefore,optimisationofMRimagingparameterstocompensateforthepresenceofthisprosthesismaybenecessary.Themaximumartefactsize(i.e.asseenonthegradientechopulsesequence)extendsapproximately10mmrelativetothesizeandshapeofthisimplant.

This informationisbasedoninformationfromtheFoodandDrugAdministrationandtheAmericanSocietyforTesting andMaterials (ASTM) International,Designation: F2503-08. StandardPractice forMarketingMedicalDevicesandOtherItemsforSafetyintheMagneticResonanceEnvironment.

SECTION 2 ADDITIONAL INFORMATION

SECTION 2.1 ORIGIN OF GELATINVascutek uses gelatin manufactured from animals native to, and exclusively raised in the United StatesofAmerica.TheUnitedStatesofAmerica isclassifiedasanegligibleBSE riskcountryaccording to theOIEcategorisation(adoptedbytheEuropeanUnionwiththeRegulation(EC)N°722/2007).Thegelatinishydrolysedwithinapproximately14daysandisreplacedbynormaltissueincorporation.

SECTION 2.2 STERILISATIONTheseprostheseshavebeensterilisedusingEthyleneOxideandaresuppliedsterile.TheTyvek®sealonbothintermediateandinnertraysmustbeintact.Anydamagetothetraysrenderstheprosthesisnon-sterile.Note:In the event of damage to the primary packaging, the prosthesismust not be used and should be returnedimmediatelytothesupplier.

CAUTION: PROSTHESES MUST NOT BE RE-STERILISED.

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CLINICAL EXPERIENCE

Gelsoft™Abdominal Vascular RepairAprospectiveclinicaltrialwasconductedtoevaluatethesafetyandeffectivenessoftheGelsoft™vasculargraftinthetreatmentofaneurysmalandocclusivedisease,byreplacementorrepairoftheabdominalaorta.Theclinical study involved65patientsat twocenters in theUnitedStatesand100patients implantedat theGlasgowRoyalInfirmaryinScotland,UnitedKingdom.Studypatientsrangedinagefrom35to83yearsandthefemale:maleratioof1:4wastypicalofpatientsthatundergothistypeofsurgery.

UnitedStatespatientswerefollowedbyphysicalexamination,for12monthspost-operativelyandpatientsintheUnitedKingdomwerefollowed25to59monthsafter implant.Themajorendpointsof intra-operativebleedingthroughthegraftandprimarypatencywerecomparabletotheapprovedVascutekGelseal™graft.

Therewerenoadverseeventsattributedtoadysfunctionofthegraftandnograftrelatedmortality.Post-operativeincrease ingraftdiameterwasobservedduring theabdominaluseclinical trial,however thisphenomenon, isgenerallyknowntobeassociatedwithknittedvasculargrafts15,16andwasnotshowntobeclinicallysignificant.Thekeyadverseeventsrecordedduringtheabdominaluseclinicaltrialincludedbleedinganddistalembolism.Gelsoft™safetyandperformancedataforabdominaluseanalysedbygenderdidnotillustrateadifferenceinthesafetyandeffectivenessoftheGelsoft™graftinmalesandfemales.

Peripheral Vascular RepairAprospective trialwasconducted tocomparegraftpatencybetweenGelsoft™andePTFEgrafts for femoro-popliteal bypass. The clinical study involved 108 patients at three centers inAustralia. Distal anastomosiswasperformedabovethekneein75patientsandbelowthekneein33patients.Patientswerefollowedpost-operativelybyphysicalexaminationfor1to53months,withameanof19monthsandamedianof18months.Therewasnodifferencebetweentreatmentgroupsintermsofgraftprimaryandsecondarypatency.

SECTION 2.3 PACKAGINGTraysareenclosedinafoilpouchthatservesasavapourbarrierandpreservesoptimalprosthesischaracteristics.A sachet containing a desiccant is included to aid this purpose. Note:Thefoilpouchandoutertrayarenotsterile.Onlytheinnermosttraycanbeintroducedtothesterilefield.

SECTION 2.4 STORAGE CONDITIONS Storeinclean,dryareaatroomtemperature.

SECTION 2.5 ADDITIONAL LABELSAdditionallabelsareattachedforuseonpatientrecords.

SECTION 2.6 RETURNING A PROSTHESISAllexplantedprosthesesshouldbereturnedtoVascutekforanalysisassoonaspossible.IntheeventofausedprosthesisneedingtobereturnedtoVascutek,it isarequirementtohavetheprosthesis,andanyotheritemsusedintheproceduretobereturnedinanexplantsboxwhichcanbeobtainedfromVascutek’sQualityAssuranceDepartment. If required, explant kits can be requested at [email protected] or through your localdistributorandwillbeprovidedfortheretrievalandpreservationoftheexplantedprosthesisorothercomponentsfor transit to Vascutek.

SECTION 2.7 DISPOSAL OF PROSTHESESEnsurethatlocalandnationalregulatoryrequirementsforthedisposalofcontaminatedclinicalwasteproductsare adhered to.

SECTION 3 CLINICAL EVIDENCE AND REFERENCESVascutekgelatinsealedpolyestervascularprostheseshavebeenusedclinicallyforover30years.3TheuniqueVascutekgelatinsealingtheprosthesisallowsittobondwiththeantibioticRifampicin,whichminimisesthepotentialforpost-operativegraftinfection.4Alargerangeofprosthesisdesignsareavailableforsystemicvascularrepairinvolving,forexample,theaorticroot,aorticarch,thoracoabdominalaorta,axillo-bifemoralextraanatomicbypass,abdominalaortaandperipheralregions.1,5,6,7,8,9,10,11,12,13,14TheGelweave™Valsalvaprosthesishasbeenusedclinicallyforaorticrootrepair.5,6AwiderangeofbranchedGelweave™prosthesisdesignsareavailableincluding,forexample,theAnte-Flo™,Plexus, Siena, Lupiae andCoselli prostheses which cater for a variety of aortic arch and thoracoabdominalprocedures.1,7,8,9,10,11

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Gelseal™Clinicalsafetyandeffectivenessdatawascollectedfrom180abdominalapplicationsinprimarystudypatients,foraneurysmalandocclusivediseaseintheUnitedStatesandUnitedKingdom.53%ofthepatientshadnopost-surgicalcomplications,while47%hadatleastonecomplication.

Noneofthecomplicationsweredeemedbytheinvestigatorstobegraftrelated(including61eventsofischemiadistal to thegraft,whichwere thought to beasa result of diseaseprogression, poor cardiacoutput, or longischemic times during surgery). Several complications were classified as “unknown cause”. These includedcomplications such as fever with unknown origin, seroma, erythema, vomiting and diarrhoeawithout gastro-intestinalproblems,shortnessofbreathwithoutpulmonaryproblems,jointpain,renalfailureandinsensatelimb.

There were a total of 15 deaths: none were graft related. One year actuarial (freedom from post- surgicalcomplications) rates from the United States Gelseal™ patients, for patency, mortality, graft infection andthrombemboliceventswere100%,93.4%,98.5%and97.9%respectively.FortheUnitedKingdompatients,rateswere97.9%,95.8%,100%and97.9%respectively.

Gelweave™AprospectiveclinicaltrialwasconductedtoevaluatethesafetyandeffectivenessoftheGelweave™vasculargraftforreconstructionofthethoracicaorta.ThestudywasconductedatthreecentersintheUnitedStatesandinvolvedatotalof69patients(Gelweave™andcontrols).Patientswerefollowedforoneyearandevaluatedbyphysicalexamination.TheGelweave™studypopulationwas43%femaleand57%maleandrangedinagefrom37to83years.Intra-operativebloodlossthroughthegraftwasreportedin5%(2of40)ofGelweave™grafts,comparedto67%(14of21)ofnon-sealedand14%(2of14)ofsealedcontrolgrafts.Therewerenoreportsofpost-operativeblood lossthroughthegraft foranygraft type.Therewerenomorbidevents(includinggraftinfection,graftocclusionandfalseaneurysm)attributedtotheGelweave™graftandnograftrelatedmortality.Comparisonofmorbideventsbygender illustrated that theGelweave™graftwasequally safe inmalesandfemales.

REFERENCES1. Hybrid three stage repair of mega aorta syndrome with the Lupiae technique. N Troisi et al. The

JournalofThoracicandCardiovascularSurgery,March20132. Rinsing of gelatin sealed prostheses with Rifampicin and Heparin.BSiENQ#100209273. Experimental and Clinical Experience with a Gelatin Impregnated Dacron Prosthesis.JKDruryet al.

AnnalsofVascularSurgery1987;5:542-5474. Rifampin Bonded Graft European Trial: (RBGET) Meeting May1995OA.Goëau-Brissonniereet al. 5. Long-term results of the valve reimplantation technique using a graft with sinuses. R De Paulis et al.

TheJournalofThoracicandCardiovascularSurgeryVolume151,Number1,January20166. Modified Bentall Operation with Bioprosthetic Valved Conduit:Columbia University Experience. M

Tabataet al.AnnalsofThoracicSurgery2009;87:1969-19707. The “Elephant Trunk” Technique Made Easier. Eugenio Neri et al.AnnalsofThoracicSurgery2004;

78:17-188. Pan-aortic hybrid treatment of mega-aorta syndrome. A A. Shah et al.JournalofVascularSurgery,May

20119. The Gelweave Polyester Arterial Prosthesis.PUkpabiet al.JCC1995;38(4)10. Usefulness of New Branched Sealed Graft for the Replacement of Aortic Arch. H Adachi et al.

JapaneseJournalforArtificialOrgans1997;26(3):624-62811. Thoracoabdominal aortic aneurysm repair with a branched graft.Kim I.de laCruzet al. Annals of

CardiothoracicSurgery2012;1(3):381-39312. European Prospective Randomised Multi-Centre Axillo-Bifemoral Trial. C H A. Wittens et al. European

JournalofVascularSurgery1992;6:115-12313. Can Knitting Structure Affect Dilation of Polyester Bifurcated Prostheses? A Randomized Study with

the use of Helical Computed Tomography Scanning.OA.Goëau-Brissonniereet al. Journal of Vascular Surgery2000;31:157-163

14. A Prospective Randomized Multi-Centre Comparison of Expanded Polytetrafluoroethylene and Gelatin-Sealed Knitted Dacron Grafts for Femoropopliteal Bypass.BI.Robinsonet al. Cardiovascular Surgery1999;7(2):214-218

15. Post-Operative Dilation of Knitted Dacron Aortic Bifurcation Grafts. Nunn et al. Journal of VascularSurgery1990;Volume12pp.291-297

16. Long Term Dilatation of Polyester and Expanded Polytetrafluoroethylene Tub Grafts After Open Repair of Infrarenal Abdominal Aortic Aneurysms.Stollwercket al.JournalofVascularSurgery53,2011pp.1506-1513

Note: ThefollowingconfigurationsarenotapprovedinCanada:Gelseal™Ante-Flo™andPlexus.

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SECTION 4 EXPLANATION OF SYMBOLS ON PRODUCT LABELLING

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EN Use-by Date Latex-free EN

LATEX

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Batch Code Catalogue NumberEN EN

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Serial NumberEN Sterilized using Ethylene OxideEN

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EN ENDo not re-use, single use only Read Instructions before Use

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DiameterEN Usable LengthEN

Manufactured By:

VASCUTEK LtdNewmains Avenue, Inchinnan

Renfrewshire PA4 9RR, Scotland, UK

Tel: +44 (0) 141 812 5555

Part No: 301-xxx

gelsoft plus gelseal gelweave vascular prostheses...the prosthesis must be immersed in a sterile...

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