1、Carotid WALLSTENTTM 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 & 8 mm) 和 6F (10 mm) 低外廓，高柔顺性；,Carotid WALLSTENTTM 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,*Please note that reconstrainment and repositioning are subject to specific limitation
2、s. Please refer to DFU cautions and warnings for additional information.*The Carotid WALLSTENT Endoprosthesis is indicated for use in eligible patients with ipsilateral or bilateral carotid artery disease,Carotid WALLSTENTTM 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,*Free Cell Area: Measures the
3、 average area (mm2)within the perimeter of connecting struts. Smaller number = smaller free cell area.,Carotid WALLSTENTTM 颈动脉支架,支架设计-闭环 Vs. 开环,闭环支架设计Carotid WALLSTENT EndoprosthesisXact Carotid Stent开环支架设计Precise PRO Rx Nitinol Stent SystemRX Acculink Carotid Stent,Carotid WALLSTENT Endoprosthesis,
4、Precise PRO Rx Nitinol Stent System,RX Acculink Carotid Stent,Images taken by and on file at BSC. Illustrations by BSC.,Precise Pro is a trademark of Cordis Corporation, Acculink is a trademark of Abbott Cardiovascular Systems, Inc, and Xact is trademark of MedNova, 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
5、网孔面积*,Carotid WALLSTENT 闭环设计提供最大化的斑块覆盖以及光滑平整的管腔,*Testing performed on Carotid WALLSTENT Endoprosthesis 8mm x 21mm, Precise Pro RX 8mm x 40mm, RX ACCULINK 7-10mm x 40mm, Xact 7-9mm x 40mm. Bench test results may not necessarily be indicative of clinical performance. Test results shown are for models
6、deemed most typically selected for placement in common carotid artery with a reference diameter of 8mm. Other models were also tested and yielded similar results. N=3. Data on file.Precise Pro is a trademark of Cordis Corporation, Acculink is a trademark of Abbott Cardiovascular Systems, Inc, and Xa
7、ct is trademark of MedNova, Ltd.,*Free Cell Area: 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,Photographs taken by Boston Scientific Corporation,闭环支架设计,Carotid WALLSTENT 闭环设计提供最大化的斑块覆盖以及光滑平整的管腔,Does Carotid Stent Design Influence Outcomes? R. M. Bersin, Catheterization and Cardiovascular Interventions 2008; 72:86
8、3866,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。Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. A retrospective analysis of 30 day outcomes of a carotid artery stenting multicenter database consisting of 3179 consecutive patientsSPACE, a retrospective, randomized trial
9、of carotid artery stenting versus endarterectomy in standard surgical risk patients with symptomatic carotid artery stenosesSchillinger M, Gschwendtner M, Reimers B, et al. Does carotid stent cell design matter? A retrospective, nonrandomized review of a carotid artery stenting multicenter database
10、consisting of 1,684 consecutive patients,Does Carotid Stent Design Influence Outcomes? Bersin. Catheterization and Cardiovascular Interventions 2008; 72:863866.,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,目的: 明确颈动脉支架设
11、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, Donato et al. - ItalyCremonesi, Castriota - Italy,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endov
12、asc Surg 2007;33:135-141.,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,闭环支架定义为支架网孔面积 5.0mm2例如Precise Rx Nitinol Stent SystemRX Acculink Carotid Stent,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting
13、? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,Precise is a trademark of Cordis Corporation, Acculink is a trademark of Abbott Cardiovascular Systems, Inc, and Xact is trademark of MedNova, Ltd.,第30天事件：闭环 vs. 开环支架设计TIA, 死亡, 大和小卒中,Does Free Cell Area Influence the Outcome in Carotid Arter
14、y Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;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%) (p0.0001),Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,N=3179P=0.005,N=1317P0.0001,N=1862P=1.0
15、,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;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,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,对于症状性
16、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%) (p0.0001),N=3179P0.0001,N=1317P0.0001,N=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,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et a
17、l. Eur J Vasc Endovasc Surg 2007;33:135-141.,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,总结,四个中心的30天结果回顾性分析N=3179 CAS patients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%) (p0.0001)对于症状性患者，手术30天以后的主要事件发生率差异显
18、著，开环支架设计(6.3%) VS 闭环支架设计(1.3%) (p0.0001),Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,Carot
19、id WALLSTENT 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,*Please note that reconstrainment and repositioning are subject to specific limitations. Please refer to DFU cautions and warnings for additional information.*The Carotid WALLSTENT Endoprosthesis is indicated
20、 for use in eligible patients with ipsilateral or bilateral carotid artery disease,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,Carotid WALLSTENT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,Testing performed on Carotid WALLSTENT Endoprosthesis 8mm x 21mm, Precise Pro RX 8mm x 40mm, RX ACCULINK 7-10mm x 40mm, Xact 7-9mm x 40mm.
21、Bench test results may not necessarily be indicative of clinical performance. Test results shown are for models deemed most typically selected for placement in common carotid artery with a reference diameter of 8mm. Other models were also tested and yielded similar results. N=3. Data on file.Precise
22、 Pro is a trademark of Cordis Corporation, Acculink is a trademark of Abbott Cardiovascular Systems, Inc, and Xact is trademark of MedNova, Ltd.,Delivery Force: Bench test that measures the maximum force required to navigate through a bench model of tortuosity. Smaller values = Less force required,低
23、外廓的输送系统,匹配的导引鞘* (Vessel Size),*Information excerpted from respective DFUs.,Precise Pro is a trademark of Cordis Corporation, Acculink is a trademark of Abbott Cardiovascular Systems, Inc, and Xact is trademark of MedNova, Ltd.,低外廓设计允许其通过5F or 6F血管鞘,Carotid WALLSTENT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
24、用,The pin-and-pull delivery systemis designed to simplify delivery,Carotid WALLSTENT Endoprosthesis Delivery System Final Assembly. Image property of Boston Scientific Corporation. Not necessarily to scale.,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,*Please note that reconstrain
25、ment and repositioning are subject to specific limitations. Please refer to DFU cautions and warnings for additional information.*The Carotid WALLSTENT Endoprosthesis is indicated for use in eligible patients with ipsilateral or bilateral carotid artery disease,Carotid WALLSTENTTM 颈动脉支架,出色的显影性,在对比测试
26、中，与其他颈动脉支架相比，Carotid WALLSTENT是显影性最好的支架,Carotid WALLSTENT的设计使支架具有高度可视性，便于支架的精确释放,Testing performed on CarotidWALLSTENT Endoprosthesis 8mm x 21mm, Precise Pro RX 8mm x 40mm, RX ACCULINK 7-10mm x 40mm, Xact 7-9mm x 40mm. Bench test results may not necessarily be indicative of clinical performance. Tes
27、t results shown are for models deemed most typically selected for placement in common carotid artery with a reference diameter of 8mm. Other models were also tested and yielded similar results. N=3. Data on file.Precise Pro is a trademark of Cordis Corporation, Acculink is a trademark of Abbott Card
28、iovascular Systems, Inc, and Xact is trademark of MedNova, Ltd.,Radiopacity: Bench test that illustrates the visibility of a stent under C-arm underneath simulated tissue,Image courtesy of Dr. Hoffman Illustrates the in vivo visibility of Carotid WALLSTENT and the Rx Acculink Carotid stent. May not
29、be indicative of clinical performance.,. Acculink is a trademark of Abbott Cardiovascular Systems, Inc,Carotid WALLSTENT Endoprosthesis,RX Acculink Carotid Stent,出色的显影性,出色的显影性,Distal Inner RO Marker,Outer Distal RO Marker,All Photographs taken by Boston Scientific Corporation,内杆及外鞘上的可回收标记点均不透射线，帮助支架
30、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,*Please note that reconstrainment and repositioning are subject to specific limitations. Please refer to DFU cautions and warnings for additional information.*The Carotid WALLSTENT Endoprosthesis is indicated for use in eligible pat
31、ients with ipsilateral or bilateral carotid artery disease,Carotid WALLSTENTTM 颈动脉支架,独特的可回收能力*,*Please note that reconstrainment and repositioning are subject to specific limitations. Please refer to DFU cautions and warnings for additional information.,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
32、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,Carotid WALLSTENT Endoprosthesis Delivery System Final Assembly. Image property of Boston Scientific Corporation. Not necessarily to scale.,*Please note that reconstrainment and repositioning are subject
33、 to specific limitations. Please refer to DFU cautions and warnings for additional information.,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,*Please note that reconstrainment and repositioning are subject to s
34、pecific limitations. Please refer to DFU cautions and warnings for additional information.*The Carotid WALLSTENT Endoprosthesis is indicated for use in eligible patients with ipsilateral or bilateral carotid artery disease,Carotid WALLSTENTTM 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
35、颈动脉支架*临床数据支持,*Please note that reconstrainment and repositioning are subject to specific limitations. Please refer to DFU cautions and warnings for additional information.*The Carotid WALLSTENT Endoprosthesis is indicated for use in eligible patients with ipsilateral or bilateral carotid artery dise
36、ase,Carotid WALLSTENTTM 颈动脉支架,28,尺寸的正确选择,Carotid WALLSTENTTM 颈动脉支架,Carotid WALLSTENT Monorail,Carotid Wallstent的尺寸选择,选择Wallstent 根据:靶血管的最大直径支架植入部位的长度,Wallstent的完全释放直径要比靶血管的最大直径 至少大1 mm支架覆盖病变两侧的正常组织，至少各长5 mm,尺寸选择原则,Carotid Wallstent尺寸选择,32,支架直径 = 血管直径 (a) + 1 or 2 mm支架长度 (b) = 病变长度 (c) + 10 mm (两侧各超出5mm),33,30 mm,8 mm,5.4 mm,应选择何种直径的Carotid Wallsetent?,9 mm,40 mm,10 x 31,应选择何种长度的Carotid Wallsetent?,应选择哪个型号的Carotid Wallsetent?,Carotid Wallstent尺寸选择,34,34,Carotid Wallstent尺寸选择,35,
