Integra DuraGen · 9 - Sade et al What is DuraGen ® Matrix An Investment in Data ... Only Integra...
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Limit uncertainty with the most studied and proven collagen-based dural grafts Integra ® DuraGen ® Dural Regeneration Matrix
Transcript of Integra DuraGen · 9 - Sade et al What is DuraGen ® Matrix An Investment in Data ... Only Integra...
Limituncertaintywiththemoststudiedandprovencollagen-basedduralgrafts
Integra® DuraGen®
DuralRegenerationMatrix
“The Fibroblasts Use the PoresontheMatrixtoLay Down Endogenous Collagen.By6-8Weeks,theCollagen
Matrix(DuraGenMatrix)is Resorbed and is IntegratedtotheEndogenousDuraMater.The CompactStructure
ofthe(Other) Xenogenic MaterialsMayLimit the Fibroblast MigrationtotheEdgesortotheSutureHoles.
TheseProcessesdo not Constitute anIdeal SituationwithRegardstotheSealing QualityoftheMaterial.”
-Sadeetal 9
What is DuraGen® Matrix
An Investment in DataPatient outcomes are very important to you and your patients—DuraGen Matrix has more published
clinical data than any other collagen-based dural graft.
DuraGen matrix is one of the safest and most effective onlay grafts for the restoration and repair of dura mater. Itisconformableandcontoursinstantlyandeffectively
tothecomplex,moistsurfacesofthebrainandspinalcord,
rapidlysupportingtheformationofabiologicalsealtoprotect
againstCSFleakage.
The DuraGen Matrix Difference
10
5
00 Studies
1 Study0 Studies
10 Studies
Date:AsofJanuary1,2012
Integra Stryker Medtronic Codman
Integra® DuraGen® MatrixUnsurpassedClinicalData
Study NameAuthorDuraGenPatients Studied Procedure Type
The DuraGen Matrix Studies
Collagenmatrixindecompressivehemicraniectomy
ThesestudiesrepresenttheuseofDuraGenmatrixwithouttheuseofduralsealants.
ExperiencewithacellularhumanduraandbovinecollagenmatrixforduraplastyafterposteriorfossadecompressionforChiarimalformations
PosteriorFossaDecompression
Danishetal1
Horaczeketal3
EndoscopicTransnasalCraniotomy
Closureoflargeskullbasedefectsafterendoscopictransnasalcraniotomy
Harveyetal2
Collagenmatrixduraplastyforcranialandspinalsurgery:aclinicalandimagingstudy
Narotametal7
PosteriorFossaCraniectomy,LumbarLaminectomy,SupratentorialCraniotomy
DecompressiveHemicraniectomy,Cranioplasty
Efficacyandsafetyofacollagenmatrixforcranialandspinalduralreconstructionusingdifferentfixationtechniques
TOTAL:
Stendeletal10
CranialandSpinalProcedures
Collagenmatrixduraplastyforposteriorfossasurgery:evaluationofsurgicaltechniquein52adultpatients
Narotametal8 PosteriorFossaSurgery
Duralaugmentation:PartI–Evaluationofcollagenmatrixallograftsforduraldefectaftercraniotomy
Litvacketal5
FrontalCraniotomy,Suboccipital/RetrosigmoidCraniotomy,TemporalCraniotomy
Non-watertightduralreconstructioninmeningiomasurgeryresultsin439consecutivepatientsandareviewoftheliterature
Sadeetal9
IntracranialMeningiomaResection
Collagenmatrix(DuraGen)induralrepair:analysisofanewmodifiedtechnique
Narotametal6
SpinalSurgery
Duralreconstructioninmeningiomasurgery
18
56
30
79
1,453
112
52
320
439
110
237Leeetal4
IntracranialMeningiomaResection
Over 1,400 Patients in 10 Published Clinical Studies
•0%Foreignbodyresponse•1.9%Infectionrate•2.1%Leakagerate
DuraGen Dural Regenerative Matrix
•MadefromUltraPureCollagen™
•Preciselyengineeredporosityforcomplete andnaturalrepair
•Superiorconformability
1 Million Dural Grafts and Counting
10 Million Collagen Implants and Counting
OnlyIntegraDuraGengraftprovidestheconfidenceofutilizingaduralmatrixwhichhasbeenimplantedoveronemilliontimes.
Ourleadingtechnologycollagenproductshavebeenimplantedover10milliontimesinavarietyofproceduresthroughouttheworld.
Summary outcome statistics derived from the following 1o clinical studies:1. DanishSF,etal.ExperiencewithacellularhumanduraandbovinecollagenmatrixforduraplastyafterposteriorfossadecompressionforChiarimalformations. JNeurosurgPediatrics.2006;104:16-20.
2. HarveyRJ,etal.Closureoflargeskullbasedefectsafterendoscopictransnasalcraniotomy.JNeurosurg.2009;111:271-329.
3. HoraczekJA,etal.Collagenmatrixindecompressivehemicraniectomy.OperativeNeurosurgery.2008;63:ONS176-81.
4. LeeJH,etal.Duralreconstructioninmeningiomasurgery.In,LeeJH(ed):Meningiomas:Diagnosis,TreatmentandOutcome.London:Springer,2009,pp619–624
5. LitvackZN,etal.Duralaugmentation:PartI:evaluationofcollagenmatrixallograftsforduraldefectaftercraniotomy.Neurosurgery.2009;65:890-897.
6. NarotamPK,etal.Collagenmatrix(DuraGen)induralrepair:analysisofanewmodifiedtechnique.SPINE.2004;292:861-2867.
7. NarotamPK,etal.Collagenmatrixduraplastyforcranialandspinalsurgery:aclinicalandimagingstudy.JNeurosurg.2007;106:45–51.
8. NarotamPK,etal.Collagenmatrixduraplastyforposteriorfossasurgery:evaluationofsurgicaltechniquein52adultpatients.JNeurosurg.2009;111:380-386.
9. SadeB,etal.Non-watertightduralreconstructioninmeningiomasurgery:resultsin439consecutivepatientsandareviewoftheliterature.Clinicalarticle. JNeurosurg.[epubaheadofprintAugust13,2010.DOI:10.3171/2010.7.JNS10460]
10. StendelR,etal.Efficacyandsafetyofacollagenmatrixforcranialandspinalduralreconstructionusingdifferentfixationtechniques. JNeurosurg.2008;109:215-221.
MedtronicStudy:Parker,etal:ComplicationsfollowingdecompressionofChiarimalformationTypeIinchildren:duralgraftorsealant?JNeurosurg.Pediatrics2011;8:177-183.
DuraGen,DuraGenPlus,IntegraandtheIntegralogoareregisteredtrademarksofIntegraLifeSciencesCorporationintheUnitedStatesand/orothercountries.©2012IntegraLifeSciencesCorporation.Allrightsreserved.PrintedintheUSA.3KNS5156-1/12
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Integra® DuraGen® MatrixUnsurpassedClinicalData
