颈动脉产品介绍 - 支架-in service

CarotidWALLSTENTTM

颈动脉支架®支架自膨支架Elgiloy®

金属丝编制管状网眼结构2支架输送系统Monorail™导管设计，0.014“导丝输送系统；5F(6&8mm)和6F(10mm)低外廓，高柔顺性；

CarotidWALLSTENTTM

颈动脉支架闭环设计跟踪性极佳的SDS-支架输送系统卓越的显影性独特的可回收能力*

唯一经FDA批准可用于双侧治疗颈动脉支架**临床数据支持*Pleasenotethatreconstrainmentandrepositioningaresubjecttospecificlimitations.PleaserefertoDFUcautionsandwarningsforadditionalinformation.**TheCarotidWALLSTENTEndoprosthesisisindicatedforuseineligiblepatientswithipsilateralorbilateralcarotidarterydiseaseCarotidWALLSTENTTM

颈动脉支架闭环单元结构，独特的支架设计提供最大化的斑块覆盖高度的柔顺性便于使用的输送系统*FreeCellArea:Measurestheaveragearea(mm2)withintheperimeterofconnectingstruts.Smallernumber=smallerfreecellarea.CarotidWALLSTENTTM

颈动脉支架支架设计-闭环

Vs.开环闭环支架设计CarotidWALLSTENT®EndoprosthesisXact®CarotidStent开环支架设计Precise®PRORx

NitinolStentSystemRXAcculink®CarotidStentCarotidWALLSTENTEndoprosthesisPrecisePRORxNitinolStentSystemRXAcculinkCarotidStentImagestakenbyandonfileatBSC.IllustrationsbyBSC.PreciseProisatrademarkofCordisCorporation,AcculinkisatrademarkofAbbottCardiovascularSystems,Inc,andXactistrademarkofMedNova,Ltd.闭环支架设计CWS与其他颈动脉支架相比，具有最小的支架网孔面积**CarotidWALLSTENT®

闭环设计提供最大化的斑块覆盖以及光滑平整的管腔

**TestingperformedonCarotidWALLSTENTEndoprosthesis8mmx21mm,PreciseProRX8mmx40mm,RXACCULINK7-10mmx40mm,Xact7-9mmx40mm.Benchtestresultsmaynotnecessarilybeindicativeofclinicalperformance.Testresultsshownareformodelsdeemedmosttypicallyselectedforplacementincommoncarotidarterywithareferencediameterof<8mm.Othermodelswerealsotestedandyieldedsimilarresults.N=3.Dataonfile.PreciseProisatrademarkofCordisCorporation,AcculinkisatrademarkofAbbottCardiovascularSystems,Inc,andXactistrademarkofMedNova,Ltd.*FreeCellArea:测量支架连接小杆周长间的平均面积数值越小=支架网孔面积越小PhotographstakenbyBostonScientificCorporation闭环支架设计CarotidWALLSTENT®

闭环设计提供最大化的斑块覆盖以及光滑平整的管腔

DoesCarotidStentDesignInfluenceOutcomes?

R.M.Bersin,CatheterizationandCardiovascularInterventions2008;72:863–866目前为止，已经完成3项有关颈动脉支架设计与临床结果的回顾性、非随机研究。DoesFreeCellAreaInfluencetheOutcomeinCarotidArteryStenting?Bosiersetal.Aretrospectiveanalysisof30dayoutcomesofacarotidarterystentingmulticenterdatabaseconsistingof3179consecutivepatientsSPACE,aretrospective,randomizedtrialofcarotidarterystentingversusendarterectomyinstandardsurgicalriskpatientswithsymptomaticcarotidarterystenosesSchillingerM,GschwendtnerM,ReimersB,etal.Doescarotidstentcelldesignmatter?Aretrospective,nonrandomizedreviewofacarotidarterystentingmulticenterdatabaseconsistingof1,684consecutivepatientsDoesCarotidStentDesignInfluenceOutcomes?

Bersin.CatheterizationandCardiovascularInterventions2008;72:863–866..DoesFreeCellAreaInfluencetheOutcomeinCarotidArteryStenting?

Bosiersetal.EurJVascEndovascSurg2007;33:135-141.目的:明确颈动脉支架设计，尤其是支架网孔面积，对于颈动脉支架术后30天卒中、死亡或TIA的影响。

30天结果的回顾性分析TIA，死亡,大和小卒中(非心肌梗死)共3179接受颈动脉支架手术的患者4个中心Bosiers,Deloose-BelgiumPeeters,Verbis-BelgiumSetacci,Donatoetal.-ItalyCremonesi,Castriota-ItalyDoesFreeCellAreaInfluencetheOutcomeinCarotidArteryStenting?Bosiersetal.EurJVascEndovascSurg2007;33:135-141.DoesFreeCellAreaInfluencetheOutcomein

CarotidArteryStenting?

Bosiersetal.EurJVascEndovascSurg2007;33:135-141.

闭环支架定义为支架网孔面积<5.0mm2例如CarotidWALLSTENT®EndoprosthesisXACT®Carotid

Stent开环支架定义为支架网孔面积>5.0mm2例如Precise®Rx

NitinolStentSystemRXAcculink®CarotidStentDoesFreeCellAreaInfluencetheOutcomeinCarotidArteryStenting?Bosiersetal.EurJVascEndovascSurg2007;33:135-141.PreciseisatrademarkofCordisCorporation,AcculinkisatrademarkofAbbottCardiovascularSystems,Inc,andXactistrademarkofMedNova,Ltd.第30天事件：闭环

vs.开环支架设计

TIA,死亡,大和小卒中DoesFreeCellAreaInfluencetheOutcomeinCarotidArteryStenting?Bosiersetal.EurJVascEndovascSurg2007;33:135-141.对于症状性患者，术后第30天的主要事件发生率差异显著开环支架设计(7.0%)VS

闭环支架设计(2.2%)(p<0.0001)DoesFreeCellAreaInfluencetheOutcomein

CarotidArteryStenting?

Bosiersetal.EurJVascEndovascSurg2007;33:135-141.

N=3179P=0.005N=1317P<0.0001N=1862P=1.0DoesFreeCellAreaInfluencetheOutcomein

CarotidArteryStenting?

Bosiersetal.EurJVascEndovascSurg2007;33:135-141.

术后=(TIA,卒中,死亡)直到术后30天发生闭环

vs.开环支架设计DoesFreeCellAreaInfluencetheOutcomeinCarotidArteryStenting?Bosiersetal.EurJVascEndovascSurg2007;33:135-141.对于症状性患者，手术30天以后的主要事件发生率差异显著开环支架设计(6.3%)VS闭环支架设计(1.3%)(p<0.0001)N=3179P<0.0001N=1317P<0.0001N=1862P=1.0患者评估由独立神经病学医师进行神经学上的局限性回顾性的研究非随机设计可能导致在选择时会因特定病变类型有所偏向注册数据受制于自我审计技术复杂性没有评估，结果没有经过风险校正有必要进行前瞻性的随机研究来比较不同支架网孔面积以得到最终结论DoesFreeCellAreaInfluencetheOutcomeinCarotidArteryStenting?Bosiersetal.EurJVascEndovascSurg2007;33:135-141.DoesFreeCellAreaInfluencetheOutcomein

CarotidArteryStenting?

Bosiersetal.EurJVascEndovascSurg2007;33:135-141.

总结四个中心的30天结果回顾性分析N=3179CASpatients对于症状性患者，术后第30天的主要事件发生率差异显著，开环支架设计(7.0%)VS闭环支架设计(2.2%)(p<0.0001)对于症状性患者，手术30天以后的主要事件发生率差异显著，开环支架设计(6.3%)VS闭环支架设计(1.3%)(p<0.0001)DoesFreeCellAreaInfluencetheOutcomeinCarotidArteryStenting?Bosiersetal.EurJVascEndovascSurg2007;33:135-141.DoesFreeCellAreaInfluencetheOutcomein

CarotidArteryStenting?

Bosiersetal.EurJVascEndovascSurg2007;33:135-141.

CarotidWALLSTENT®Endoprosthesis闭环设计跟踪性极佳的SDS-支架输送系统卓越的显影性独特的可回收能力*

唯一经FDA批准可用于双侧治疗颈动脉支架**临床数据支持*Pleasenotethatreconstrainmentandrepositioningaresubjecttospecificlimitations.PleaserefertoDFUcautionsandwarningsforadditionalinformation.**TheCarotidWALLSTENTEndoprosthesisisindicatedforuseineligiblepatientswithipsilateralorbilateralcarotidarterydisease跟踪性极佳的SDS-支架输送系统独特的编织结构提高支架的柔顺性CarotidWALLSTENT®具有高度柔顺的输送系统，提供卓越的跟踪性以通过扭曲病变TestingperformedonCarotidWALLSTENTEndoprosthesis8mmx21mm,PreciseProRX8mmx40mm,RXACCULINK7-10mmx40mm,Xact7-9mmx40mm.Benchtestresultsmaynotnecessarilybeindicativeofclinicalperformance.Testresultsshownareformodelsdeemedmosttypicallyselectedforplacementincommoncarotidarterywithareferencediameterof<8mm.Othermodelswerealsotestedandyieldedsimilarresults.N=3.Dataonfile.PreciseProisatrademarkofCordisCorporation,AcculinkisatrademarkofAbbottCardiovascularSystems,Inc,andXactistrademarkofMedNova,Ltd.DeliveryForce:Benchtestthatmeasuresthemaximumforcerequiredtonavigatethroughabenchmodeloftortuosity.Smallervalues=Lessforcerequired低外廓的输送系统直径≤8mm直径>8mmCarotidWALLSTENT®Endoprosthesis5F6FXact®CarotidStent6F6FRXAcculink®CarotidStent6F6FPrecise®PRORxNitinolStentSystem5F6F匹配的导引鞘*(VesselSize)*InformationexcerptedfromrespectiveDFUs.PreciseProisatrademarkofCordisCorporation,AcculinkisatrademarkofAbbottCardiovascularSystems,Inc,andXactistrademarkofMedNova,Ltd.低外廓设计允许其通过5For6F血管鞘

CarotidWALLSTENT®的低外廓支架输送系统使其具有卓越的跟踪性以通过迂曲的解剖结构便于使用Thepin-and-pulldeliverysystemisdesignedtosimplifydeliveryCarotidWALLSTENT®EndoprosthesisDeliverySystemFinalAssembly.ImagepropertyofBostonScientificCorporation.Notnecessarilytoscale.闭环设计跟踪性极佳的SDS-支架输送系统卓越的显影性独特的可回收能力*

唯一经FDA批准可用于双侧治疗颈动脉支架**临床数据支持*Pleasenotethatreconstrainmentandrepositioningaresubjecttospecificlimitations.PleaserefertoDFUcautionsandwarningsforadditionalinformation.**TheCarotidWALLSTENTEndoprosthesisisindicatedforuseineligiblepatientswithipsilateralorbilateralcarotidarterydiseaseCarotidWALLSTENTTM

颈动脉支架出色的显影性在对比测试中，与其他颈动脉支架相比，CarotidWALLSTENT是显影性最好的支架CarotidWALLSTENT®的设计使支架具有高度可视性，便于支架的精确释放TestingperformedonCarotidWALLSTENTEndoprosthesis8mmx21mm,PreciseProRX8mmx40mm,RXACCULINK7-10mmx40mm,Xact7-9mmx40mm.Benchtestresultsmaynotnecessarilybeindicativeofclinicalperformance.Testresultsshownareformodelsdeemedmosttypicallyselectedforplacementincommoncarotidarterywithareferencediameterof<8mm.Othermodelswerealsotestedandyieldedsimilarresults.N=3.Dataonfile.PreciseProisatrademarkofCordisCorporation,AcculinkisatrademarkofAbbottCardiovascularSystems,Inc,andXactistrademarkofMedNova,Ltd.Xact®StentProtege®StentRXAcculink®StentPrecise®

ProNitinolStentCarotidWALLSTENTRadiopacity:BenchtestthatillustratesthevisibilityofastentunderC-armunderneathsimulatedtissueImagecourtesyofDr.Hoffman

IllustratestheinvivovisibilityofCarotidWALLSTENTandtheRxAcculinkCarotidstent.Maynotbeindicativeofclinicalperformance..

AcculinkisatrademarkofAbbottCardiovascularSystems,Inc,CarotidWALLSTENT®EndoprosthesisRXAcculink®CarotidStent出色的显影性出色的显影性DistalInnerROMarkerOuterDistalROMarkerAllPhotographstakenbyBostonScientificCorporation内杆及外鞘上的可回收标记点均不透射线，帮助支架的定位闭环设计跟踪性极佳的SDS-支架输送系统卓越的显影性独特的可回收能力*

唯一经FDA批准可用于双侧治疗颈动脉支架**临床数据支持*Pleasenotethatreconstrainmentandrepositioningaresubjecttospecificlimitations.PleaserefertoDFUcautionsandwarningsforadditionalinformation.**TheCarotidWALLSTENTEndoprosthesisisindicatedforuseineligiblepatientswithipsilateralorbilateralcarotidarterydiseaseCarotidWALLSTENTTM

颈动脉支架独特的可回收能力**Pleasenotethatreconstrainmentandrepositioningaresubjecttospecificlimitations.PleaserefertoDFUcautionsandwarningsforadditionalinformation.CarotidWALLSTENT®的独特设计使其可以重新回收再释放，帮助支架的精确释放独特的导管结构和支架设计使支架在其在释放少于50%时都可以回收再释放DFU中与回收相关的注意事项*:只有在必要时才进行回收当支架已解除斑块时，应该严格避免回收回收次数不能超过2次不可回收标记点CarotidWALLSTENT®EndoprosthesisDeliverySystemFinalAssembly.ImagepropertyofBostonScientificCorporation.Notnecessarilytoscale.*Pleasenotethatreconstrainmentandrepositioningaresubjecttospecificlimitations.PleaserefertoDFUcautionsandwarningsforadditionalinformation.独特的可回收能力*显示支架回缩的“不可回收点”只要外鞘的回撤未超过不可回收标记点，医生都可以对支架进行回收重新释放（不超过2次，未接触斑块）闭环设计跟踪性极佳的SDS-支架输送系统卓越的显影性独特的可回收能力*

唯一经FDA批准可用于双侧治疗颈动脉支架**临床数据支持*Pleasenotethatreconstrainmentandrepositioningaresubjecttospecificlimitations.PleaserefertoDFUcautionsandwarningsforadditionalinformation.**TheCarotidWALLSTENTEndoprosthesisisindicatedforuseineligiblepatientswithipsilateralorbilateralcarotidarterydiseaseCarotidWALLSTENTTM

颈动脉支架闭环设计跟踪性极佳的SDS-支架输送系统卓越的显影性独特的可回收能力*

唯一经FDA批准可用于双侧治疗颈动脉支架**临床数据支持*Pleasenotethatreconstrainmentandrepositioningaresubjecttospecificlimitations.PleaserefertoDFUcautionsandwarningsforadditionalinformation.**TheCarotidWALLSTENTEndoprosthesisisindicatedforuseineligiblepatientswithipsilateralorbilateralcarotidarterydiseaseCarotidWALLSTENTTM

颈动脉支架28尺寸的正确选择CarotidWALLSTENTTM

颈动脉支架CarotidWALLSTENT®Monorail®支架输