simply smart - medtronicoptimized composite mesh after laparoscopic ventral repair. may 2013. 9....
TRANSCRIPT
Smart designInnovative mesh streamlines performance
∙ Exclusive 3-D mesh structure delivering reinforced textile strength1 and significanttissueingrowthsupport2
∙Mesh transparency for improved anatomy visualization during placement3
∙Establishedcollagenbioabsorbablefilmtechnologywithimpressiveresistanceto surgical handling4,5
∙Comprehensive shape and size portfolio for small, medium, and large defects4,6
Smart handlingExperience simplicity in hernia repair
∙ Designed for easy mesh deployment3
∙ Centering and orientation marking for accurate mesh positioning3,4,†
∙Abdominalwallclingingeffectforsimplifiedmesh placement3,7,‡
Smart repairDesignedtoofferyour patients optimized hernia repair performance
∙ Excellent tissue integration8
∙ Minimized visceral attachment9
∙ Good level of neoperitonization and better minimizing tissue attachment comparedwithBardDavolVentralight™* ST mesh10,§
∙ Helping to meet patients’ physiological needs through balanced mesh mechanical properties1,11,12
† If the mesh is not cut (refer to Instructions for Use). ‡ Exceptincaseswheretransfascialsuturesareusedaswellasmeshesinopenapproach.§ Fourweeksafterimplantation.
Symbotex™ composite mesh for ventral hernia repair
Exclusive 3-D mesh structure1
Stronger fixation with ReliaTack™ Articulating Reloadable Fixation Device 14,†
Histologicalpictureofmeshimplantationatfourweeksinananimalmodel15
∙Oneweekafterimplantation,mesothelialcellscolonizedthesurfaceofthebioabsorbablefilm,whichisintactandcontinuous.Ontheparietalside,severaltypesofcellscolonizedthe3-Dstructureofthetextile,includingfibroblasts,whichparticipateinthesynthesisoftheneo-collagen.
∙Twoweeksafterimplantation,mesothelialcellsbegintodegradethebioabsorbablefilm.Ontheparietalside,thetextilestartstobeintegratedintotheabdominalwall,whilekeepingits3-Dstructure and porosity.
∙Fourweeksafterimplantation,themeshisintegratedintotheabdominalwall.Noinflammatoryreaction is observed.
3-D monofilamenttextile
Large pore
Histologicalsectioninaratatfourweeks
3-Dmonofilament macroporous textile Pore size13: 2.1 mm x 3.0 mm Density13: 64 g/m² Thickness13: 0.7 mm
Bioabsorbablecollagenfilm4,5
Orientation marking
†Benchtoptestingbasedoncommerciallyavailableabsorbableandpermanentfixationdevices,whichincludetheSECURESTRAP™*, SorbaFix™*,OptiFix™*, CapSure™*, ProTack™,andReliaTack™deviceswithstandardpurchasetackswhentheshaftisangledat30,45,65,and90degrees.ReliaTack™devicedeeppurchasetackshearpulltestperformedinsyntheticfoam.Resultsmaynotcorrelatetoperformanceinanimal or cadaveric tissue, or performance in humans.
Contact your Medtronic sales representative and learn more at medtronic.com/symbotex
IMPORTANT: Please refer to the package insert for complete instructions, contraindications, warnings and precautions.
References
1. Basedoninternalbenchtoptestreport#TEX044.October2014.2. CobbW,LomantoD,LecuivreJ,etal;HerniaCenter,GreenvilleHospitalSystemUniversityMedicalCenter.Comparativeanalysisoftheperformanceofaseriesofmeshesbasedonweightandporesizein
a novel minipig hernia model. Hernia. 2013;17(suppl1):S54.3. Basedoninternaltestreport#0901CR252a,PreclinicalstudyonpigsbysurgeonsfordesignvalidationofSymbotex™. June 2013. 4. Basedoninternaldesignvalidationreport#0901CR249a,ResultsofaninternallysponsoredpreclinicalstudycarriedoutonaporcinemodeltovalidatethedesignofSymbotex™ composite mesh. June 2013. 5. Basedoninternaldesignverificationreport#0901CR247b.July2013.6. Basedoninternalsizeandshapecomparisonchart.7. Basedoninternaltestreport#0901CR261a,ObservedclingingeffectofSymbotex™ during design validation. July 2013. 8. BasedonNAMSAreport#162750,usingaporcinemodeltoevaluatelocaltissueeffectsandtissueintegrationofSymbotex™ composite mesh vs. Parietex™
optimized composite mesh after laparoscopic ventral repair. May 2013. 9. BasedonNAMSAreport#162750,Localtissueeffects,tissueintegrationandminimizingtissueattachmentperformanceofSymbotex™ composite mesh in a rat caecal abrasion model. May 2013. 10. BasedonNAMSAreport#163905,Symbotex™compositemeshvs.competitorsinapigbowelabrasionmodel.October2013.11. LepereM,ZaranisC,KhalilH,etal.Twoyearresultsofincisionalandprimaryventralherniarepairwithanovelthree-dimensionaltextilecompositemesh:TheSymCHroregistrystudy.Abstractpresentedin
IHC Congress 2018.12. Köckerlingetal.2017-TheImportanceofRegistriesinthePostmarketingSurveillanceofSurgicalMeshes.Annals of Surgery, 2017. doi: 10.1097/SLA.0000000000002326 13. Basedoninternaltestreport#TEX001.February2017.14. Basedoninternaltestreport#RE00010135-1,ReliaTack™devicedeeppurchasetackshearpulltestperformedinsyntheticfoam.Resultsmaynotcorrelatetoperformanceinanimalorcadaverictissue,
or performance in humans. p-value=0.00. October 2015.15. BasedonNAMSAstudy#163905andhistologicalobservationsreport#0901CR263a.May2013.
Laparoscopic ventral repair (all sizes indicated in cm)
Open ventral repair
40 x 24 SYM4024E
34 x 20 SYM3420E
25 x 15 SYM2515E
20 x 12 SYM2012E
17 x 10 SYM1710E
30 x 20 SYM3020
37 x 28 SYM3728
42 x 32 SYM4232
25 x 20 SYM2520
20 x 15 SYM2015
15 x 10 SYM1510
8SYM8OS
15 x 10 SYM1510OS
20 x 15 SYM2015OS
25 x 20 SYM2520OS
30 x 20 SYM3020OS
9 diameter SYM9
12 diameter SYM12
15 diameter SYM15
20 diameter SYM20
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