Gelweave™Branched Grafts with Radiopaque Markers Suitable for Debranching and Associated Hybrid Procedures

2

3

Branched Grafts with Radiopaque Markers Suitable for Debranching and Associated Hybrid Procedures

• Theuseofsidebranchgraftsisintendedtofacilitatethedeliveryof

endovasculardevicesinhighrisksurgicalpatients1

• Sidebranchgraftsmaybeusedinthetreatmentofthoracicand

thoracoabdominalaneurysms1,2

• Debranchingandhybridproceduresofcomplexthoracicand

thoracoabdominalaneurysmsexpandthefieldofendovascularstentgrafting

inhighrisksurgicalpatients3,5

• Althoughopensurgicalrepairremainsthegoldstandardtreatmentforfit

patients,hybridproceduresincludingdebranchingofthearchvesselsfor

aorticarchpathologyfollowedbycompletionoftheendovascularprocedure

arefeasibleinselectedhighsurgicalriskpatients4

• Theuseofhybridproceduresprovidesanalternativetoopenrepairinhigh

risksurgicalpatientswithcomplexaorticpathology3,4,5

• Patentedradiopaquemarkerdesigns6

• Theradiopaquemarkers

-improvein vivovisualization7

-facilitateprecisestentgraftpositioning8

Overall,theliteratureconcludesthattheseproceduresprovideatherapeutic

alternativetopatientswhowouldbeotherwiseinoperable.1

4

DesignedinassociationwithGiampiero Esposito,MD,ChiefofCardiovascularSurgeryDepartment,SantaMariaHospital,Bari,Italy.

Bore Size Length Bore Size Length (mm) (cm) (mm) (cm)

Catalogue No.

Body Branches

20 40 22 40 24 40 26 40 28 40 30 40 32 40 34 40

A B C D 10108101010810101081010108101010810101081010108101010810

734020CX4RMS734022CX4RMS734024CX4RMS734026CX4RMS734028CX4RMS734030CX4RMS734032CX4RMS734034CX4RMS

A B C D 4030303040303030403030304030303040303030403030304030303040303030

Patentedradiopaquemarkerdesign

Brachiocephalictrunkbranch

Leftcommoncarotidarterybranch

Leftsubclavianartery,perfusionsidebranchorendovascularsystemdeliverybranch

Leftsubclavianarteryorbypasstothevisceralarteries

Aorticarchsection

A

B

C

D

30o

Lupiae™ Branched Graft

5

Examples of Completed Debranching Hybrid Procedures

Ascendingaorta,arch&descendingaorticaneurysm

Supra-renalthoracoabdominalaorticaneurysminvolvingtheascendingaorta

Radiopaquemarkersimprovein vivovisualization

6

Branched Arch Graft with RadiopaqueMarkers

DesignedinassociationwithJoseph E Bavaria, MD,ProfessorofSurgeryandDirectoroftheThoracicAorticSurgeryProgram,UniversityofPennsylvania,Philadelphia,PA.

BoreSizes UsableLengths Catalogue(mm) (cm) No.

A B C D E A B C D E 221012882030151530732022CX4RM241012882030151530 732024CX4RM261012882030151530 732026CX4RM281012882030151530 732028CX4RM301012882030151530 732030CX4RM321012882030151530 732032CX4RM341012882030151530732034CX4RM

A

20o

20o

45o

B

CD

E

Leftsubclavianarterybranch

Leftcommoncarotidarterybranch

Brachiocephalictrunkbranch

Perfusion/endovascularsystemdeliverybranch

Aorticarchsection

Radiopaquemarkersx2

=radiopaquemarker

7

Thoracic Arch Graft with Radiopaque Marker

DesignedinassociationwithG. Chad Hughes, MD,AssistantProfessorofSurgery,DirectoroftheThoracicAorticSurgeryProgram,SectionofCardiovascular&ThoracicSurgery,DukeUniversityMedicalCenter,Durham,NC.

BoreSizes UsableLengths Catalogue(mm) (cm) No.A B C A B C 12108 222513 732212/10/8CRM141010 222513 732214/10/10CRM

A

20o

B

C

100o

Joinstoaorticarch

Brachiocephalictrunkbranch

Leftcommoncarotidarterybranch

Perfusion/endovascularsystemdeliverybranch

Radiopaquemarker

=radiopaquemarker

8

Thoracoabdominal Graft with Radiopaque Markers

C

45o

45o

B

A

F

45o

45o

D

E

Note:BranchBoffsetat45otosectionA.Radiopaquemarkerunderneathbranch.

Celiacaxis

Oversewn

Superiormesentericartery

Leftrenalartery

Rightrenalartery

Joinstoiliacartery

Perfusion/endovascularsystemdeliverybranch(removedandoversewnafterintroductionoftheendovasculargraft)

Radiopaquemarkersx9

=radiopaquemarker

9

Designedinassociationwith~G. Chad Hughes, MD,AssistantProfessorofSurgery,DirectoroftheThoracicAorticSurgeryProgram,SectionofCardiovascular&ThoracicSurgery,DukeUniversityMedicalCenter,Durham,NC.Richard L. McCann, MD,ProfessorofSurgery,DivisionofGeneralSurgery,VascularSurgery,DukeUniversityMedicalCenter,Durham,NC.

Example of a Completed Abdominal Debranching and Thoracoabdominal Hybrid Procedure

Endovasculargraft

Celiacaxis

Rightrenalartery

Superiormesentericartery

Leftrenalartery

Iliacartery

IllustrationfromHughesGC.et al.9

BoreSizes UsableLengths Catalogue(mm) (cm) No.

A B C D E F A B C D E F 14108866 2525252525257314886/6/10BRM14108888 252525252525 7314888/8/10BRM

10

Perfusion/endovascularsystemdeliverybranch

Joinstoaorticarch,abdominalaortaoriliacartery

Aorticarchorrenal/visceralarterybranches

Radiopaquemarker

Trifurcate with Side Branch and Radiopaque Marker

DesignedinassociationwithGiampaolo Zoffoli, MD, DepartmentofCardiovascularSurgery,Ospedaledell’Angelo,Venice,Italy.

Note:BranchBoffsetat30otosectionA.

B

DC

A

E

25o

BoreSizes UsableLengths Catalogue(mm) (cm) No.

A B C D E A B C D E 12101066 1515303030 731206/10/10RM14101077 1515303030 731407/10/10RM16101088 1515303030 731608/10/10RM1610888 1515303030 731608/8/10RM

=radiopaquemarker

11

References

1. LumsdenAB.et al.(2007).HybridInterventionsforComplexAortic Pathology.EndovascularToday,November;80–85.

2. BlackSA.et al.(2006).ComplexThoracoabdominalAortic Aneurysms:EndovascularExclusionwithVisceralRevascularization. JournalofVascularSurgery,Vol.43,No.6;1081–1089.

3. ZhouWet al.(2006).HybridApproachtoComplexThoracicAortic AneurysmsinHigh-riskPatients:SurgicalChallengesandClinical Outcomes.JournalofVascularSurgery,Vol.44,No.4;688–693.

4 ChiesaR.et al.(2008).EndovascularTreatmentofAorticArch Aneurysms.JornalVascularBrasileiro,Vol.7,No.2;90–98.

5. MilewskiRK.et al.(2010).HaveHybridProceduresReplacedOpenAorticArchReconstructioninHighRiskPatients?AComparativeStudyofElectiveOpenArchDebranchingwithEndovascularStentGraftPlacementandConventionalElectiveOpenTotalandDistalAorticArchReconstruction.TheJournalofThoracicandCardiovascularSurgery,Vol.140,No.3;590–597.

6. EuropeanPatentNumber:1736116B1.

7. CarroccioAet al.(2005).AorticArchandDescendingThoracic AorticAneurysms:ExperiencewithStentGraftingforSecond-Stage “ElephantTrunk”Repair.Vascular,Vol.13,No.1;5–10.

8. DataonfileatVascutekLtd.

9. HughesGC.etal.(2011).Pan-aorticHybridTreatmentof Mega-aortaSyndrome.JournalofVascularSurgery,Vol.53,No.5; 1398-1401.

ClinicalpapersavailableonrequestfromVascutekLtd.

12

Manufacturedby:VASCUTEK,aTERUMOCompany

NewmainsAvenue,InchinnanRenfrewshirePA49RR,Scotland,UK

Tel:(+44)1418125555Fax:(+44)1418127170

www.vascutek.com

B299/1

DistributedintheUSAby:TerumoCardiovascularSystems6200JacksonRoadAnnArborMI48103-9300CustomerService:888-758-8000AfterHours:888-580-5058Fax:800-292-6551www.terumo-cvs.com