Customer Value Added Support Internationaltrainingworkshops.

Caseplanning:

3DTeraReconimagingsoftwaretechnologyforlearningcurvecasesizingreports.

Fieldsizingsupportviaspecialistsandsizingguide.

Clinicalandtechnicalproctorscaseattendance.

‘Pickfromstock’widerangeofgraftsizes.

‘Special’(SP)non-stockgraftsizesbuiltbyrequest.

European Multi-Centre Arbiter II study† results AllAAAshadhigh-angledinfra-renalnecks(range70°–90°)andplacementwaswelltolerated.

Lowoccurrenceofdevicedeploymentevents.

Incidenceofendoleaksat30dayswassuperiortothatofthecomparatorhistoricaldataset.

30-dayand6-monthfollowupsshownoreportsofdevicerupture,migration,stentfracture,lossofpatency,vesselperforation,significantobstructionorconversiontoopenrepair.

Allpatientsatsixmonthsfollowuphadstableorshrinkinganeurysmsacs.

RADAR Registry Results TheRetrospectiveAorfix™DatARetrieval(‘RADAR’)voluntaryinternationalregistryincludes

datafrom931caseswithafollowuprangeupto7yrs(asofMarch2010).

AwidespectrumofpatientshavebeensuccessfullytreatedincludingsignificantnumbershavingAAAswithseverelyanglednecksand/ortortuousiliacs.

Despitethechallengingnatureofmanycases,anoverallTypeIaendoleakrateof1.4%hasbeenseen.

RegisteredinEnglandandWalesRegNo.2998639 ART-MS-019-v6/08/2010©2010byLombardMedicalTechnologiesPLC.Allrightsreserved. NotforDistributionintheUSA*CEMarked,pleaserefertocurrentAorfix™IFU. †DataonfileLombardMedicalTechnologiesPLC.April2009

CardiovascularDevicesDivision,AnsonMedicalLimited,4TridentPark,BasilHillRoad,Didcot,Oxon,OX117HJ,UK.Tel:+44(0)1235750800,Fax:+44(0)1235750879.www.lombardmedical.com

isatrademarkofAnsonMedicalLimitedawhollyownedsubsidiaryofLombardMedicalTechnologiesPLC

Aorfix™ Clinical Results

Feature Neck angle < 60° Neck angle ≥ 60°

Eligiblecasesfor1yearfollowup 233 143

MeanAneurysmNeckAngle(range0°-123º) 31° 79°

Stentmigration(>30daysupto12months) 0.0% 0.0%

Wirefracture(>30daysupto12months) 0.0% 0.0% The only device labelled* for the highest angulations

Aorfix™ gives you technology that conforms to patient anatomy, optimising both procedure and post-operative performance.

The Anatomy of Technology Durable, Flexible & AdaptableAorfix™ gives you the opportunity for single-intervention success by adapting to anatomy during and after the implantation.

Electro-polishednitinolwireconstructiongivesexcellentdurabilitywhilefollowingthebody’smovements.Fabricqualitygivesimprovedcontouringtolandingzones.Flexibleconstructionmaintainspatencyandresistsmigrationastheaneurysmvolumereduces.

“Aorfix™ is likely to increase the number of patients considered suitable for EVAR who were previously excluded from this type of treatment and also reduce the risk of endoleaks.”Horrocks,M.RetrospectiveAorfix™DatARetrievalRegistry(RADAR)Presentation.CharingCrossSymposium2009

“The device’s flexible design allows safe and accurate aneurysm sac exclusion in patients with highly challenging anatomy.”Balasubramaniam,K.,Hardman,J.,Horrocks,M.,Bulbulia,R.2009.TheadvantagesofAorfix™forendovascularrepairofabdominalaorticaneurysm.JournalofCardiovascularSurgery,50,2,139-143.

Radiopaque markers

Electro- polished nitinol

rings adapt to highly

angulated necks.

TortuousIliacsSource:MrD.Morrow,ConsultantVascularSurgery,Norfolk&NorwichHospital,UK.

High-AngledNeckSource:MrA.D.McLain,ConsultantVascularSurgery,RoyalGwentHospital,UK.

8 hooks provide secure

fixation.

Nitinol helical constructed

legs conform to complex iliac

anatomy.

Fishmouth for optimum

neck positioning. Excellent seal from 4 closely aligned

nitinol wires maximising radial force.

Radiopaque markers to assist

positioning.

600

400

200

00 10 20 30 40 45 50 55 60 65 70

End

ole

ak f

low

rat

e (m

l/sec

)

Neck Angulation (deg)

Aorfix™

Median endoleak flow rate at the correspondingangulation for each manufactured stent graft.

Competitor 1

Competitor 2

Competitor 3

Competitor 4

Competitor 5

Competitor 6

Competitor 7

Copyright permission providedfrom BC Decker Inc.; Vascular,Vol. 13, No. 6, pp.321-326, 2005.

Box plot comparing maximum (median, interquartilerange) pull out forces of stent grafts.

40

0

10

20

30

Pull

Ou

t Fo

rce

(N)

23.7N

Competitor 1 Competitor 2 Competitor 3 Aorfix™

Copyright permission provided from ISES Inc.;J Endovasc Ther, 2006, 13:77-84.

Aorfix™ GEN I

Aorfix™ enhances the clinician’s skills, ensuring it can be positioned optimally for long-term effectiveness.

Precise Positioning

Effective Sealing

Radiopaquemarkersonthegraftbodyandlegsallowprecisepositioning.

EffectivesealingasneckangulationincreasescomparedtoZ-stentgraftdesign.

“The Aorfix™ stent graft has the potential to decrease the incidence of proximal Type I endoleak in patients with a severely angulated aortic neck.”

Albertini,J.N.,DeMasi,M.A.,Macierewicz,J.,ElIdrissi,R.,Hopkinson,B.R.,Clément,C.,Branchereau,A.2005.Aorfix™stentgraftforabdominalaorticaneurysmsreducestheriskofproximalTypeIendoleakinangulated

necks:bench-teststudy.Vascular,13,6,321-326.

Theultraflexibledeliverysystemwithitsflexibletipallowscontrolledstep-by-stepgraftdeploymentinanglesupto90°.

Aorfix™ Stays Where You Place It

Radiopaquemarkers

Interlockinghelicaldesigngivessecureiliaclimbengagement,asthedevicechangeswithanatomyovertimeresistingdislocationriskforTypeIIIendoleak.

AnalysisofStentGraftFailurePullOutForces

Inter-locking helical design

8coplanarhooksaredesignedtomaximisefixationsecurityandresistgraftmigration.

Hinchliffe,R.J.,Natarajan,S.,Hopkinson,B.R.2006.Invitroanalysisofmodularaorticstentgraftfailure.JournalofEndovascularTherapy,13,77-84.

Aorfix™ Step-by-Step Sizing Guide UsethefollowingstepstoassessthemostappropriatesizeofAorfix™device

foragivenCTscan:

Please refer to the Aorfix™ stock list when selecting graft sizes for immediate ordering. Special (SP) non stock sizes may be ordered with a lead time of approximately 4 weeks.

1 Access Vessel Size and Quality: assessthediameterandqualityoftheaccessvesselsinrelationtotheAorfix™deliverysystemsizes:22Frouterdiameterforthemainbody.20Frouterdiameterforthecontralateralleganddistalextensions.

2 Ipsilateral Side:determinewhichsideofthepatientwillbeusedastheipsilateralside.Considerfactorssuchasthedirectionanddegreeofproximalneckangulation,iliacvesseltortuosityandaccessvesseldimensions.

3 Proximal Neck Length:measurethelengthfromtheinferiormarginofthedistalrenalarterytoimmediatelysuperiortothestartofaneurysmaldilationtodeterminethelengthofproximalneck.

4 Proximal Diameter (D1):measuretheaorticdiameteratseverallevelsintheproximalneck.Measurediametersfrominternalwalltointernalwall.Determinethelargestdiameterintheproximalneck.OversizethisdiametertodeterminetheD1graftdiameter.RefertotheIFUforrecommendedoversizingparameters.

5 SMA to Distal Renal Distance: measurethelengthbetweentheinferiormarginoftheSMAandtheinferiormarginofthedistalrenalartery.

6 Graft Main Body Length (L1):measurethelengthfrominferiormarginofthedistalrenalarterytotheaorticbifurcation.Thedistalopeningofthecannulationsocketwillusuallyliebetween10and30mmabovetheaorticbifurcation.ChooseanappropriateL1fromthelengthsavailable.

7 Diameter at the Cannulation Socket:measurethediameteratthelevelofthecannulationsocket.

8 Aortic Bifurcation Diameter:measurethediameterattheleveloftheaorticbifurcation.

9 Ipsilateral Leg Length (L2):measurethelengthfromthelevelofthecannulationsockettotheipsilateralcommoniliacarterybifurcation.ChooseanappropriateL2length.Thegraftlimblengthshouldnormallyresultinthedistalfishmouthlyingproximaltotheinternaliliacarteryorigin.

10 Ipsilateral leg distal diameter (D2):measurethediameteroftheselectedlandingzoneatseverallevels.OversizeappropriatelytodeterminethegraftdiameterD2.

11 Contralateral leg length (L3):measurethedistancefromthelevelofthecannulationsockettothelevelofthecontralateralcommoniliacarterybifurcation.ChooseanappropriateL3Length.

12 Contralateral leg distal diameter (D3):measurethediameterofthecommoniliacarteryatseverallevelsintheregionoftheprojectedlandingzone.OversizeappropriatelytodeterminethegraftdiameterD3.

‡Foradevicethatusesan81mmlongbodypleasemarkbothleglengthstogetcorrectproductcodefororderingontheAorfix™OrderForm.

‘Special’(SP)non-stockgraftsizesbuiltbyrequest

DISCLAIMER ItistheresponsibilityofthecliniciantoassessthesuitabilityofAorfix™fortheirpatientbyreferringtotheInstructionsforUse(IFU).TheinformationincludedinthisbrochureshouldnotbeusedasanEVARtrainingtoolanddoesnotreplaceclinicalexpertise.CliniciansshouldunderstandtheprinciplesrelatedtoendovascularstentgraftsandbetrainedinEVARtechniquespriortocommencinganyEVARprocedure.

Aorfix™ Stock Sizes

D1Measure

arangeofdiameters

intheneck.Oversizelargest

diameterby10%.

L1

Graftlengthfromdecidedproximallandingzoneto

aorticbifurcationminusapprox.

10-30mm.

Positioncannulationsocket10-30mmabove

levelofaorticbifurcation.

SMAtodistaloriginof

renalarterywith10%oversizing

fishmouthis7-12mmdeep.TakecareifSMAis≤10mmfrominf.renal

artery.

Diameteratcannulation

socketandaorticbifurcationshouldbe

≥24x12mm.

D2

D3

L2

L3

Cannulationsockettodistallandingzone

position(seenoteonstep-by-step

guide).

Cannulationsockettodistallandingzone

position(seenoteonstep-by-step

guide).

Diameteratdistal

landingzone.Oversizeby10%.

Diameteratdistal

landingzone.Oversizeby10%.

ProximalDiameterD1 24

‡81 96 111 126BodyLengthL1

63 63 63 6380 80 80 8097 97 97

SP

SP

SP

SP

SP

SP

SP

SP

SP

IpsilateralLengthL2

12

14

16

20

Dis

tal

Dia

met

erD

2

ProximalDiameterD1 26

‡81 96 111 126BodyLengthL1

63 63 63 6380 80 80 8097 97 97

SP

SP

SP

SP

SP

SP

SP

IpsilateralLengthL2

12

14

16

20

Dis

tal

Dia

met

erD

2

ProximalDiameterD1 28

‡81 96 111 126BodyLengthL1

63 63 63 6380 80 80 8097 97 97

SP

SP

SP

SP

SP SP

SP

IpsilateralLengthL2

12

14

16

20

Dis

tal

Dia

met

erD

2

ProximalDiameterD1 31

‡81 96 111 126BodyLengthL1

63 63 63 6380 80 80 8097 97 97IpsilateralLengthL2

12

14

16

20

Dis

tal

Dia

met

erD

2

SPSPSP

SP

SPSP

SPSPSP

SP

SP

SP SP

SP

ContralateralLegLengthL3 56 64 73 81 90 98 106

10

12

14

16

18

20

Dis

talD

iam

eter

D3