頸動脈產品介紹-支架-inservice

1、Carotid WALLSTENTTM 頸動脈支架,®,支架自膨支架Elgiloy® 金屬絲編制管狀網(wǎng)眼結構,2,支架輸送系統(tǒng)Monorail? 導管設計，0.014“導絲輸送系統(tǒng)；5F (6 & 8 mm) 和 6F (10 mm) 低外廓，高柔順性；,Carotid WALLSTENTTM 頸動脈支架,閉環(huán)設計跟蹤性極佳的SDS-支架輸送系統(tǒng)卓越的顯影性獨特的可回收能力* 唯一經FDA批

2、準可用于雙側治療頸動脈支架**臨床數(shù)據(jù)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 Endoprosthesi

3、s is indicated for use in eligible patients with ipsilateral or bilateral carotid artery disease,Carotid WALLSTENTTM 頸動脈支架,閉環(huán)單元結構，獨特的支架設計提供最大化的斑塊覆蓋高度的柔順性便于使用的輸送系統(tǒng),*Free Cell Area: Measures the average area (mm2)within

4、 the perimeter of connecting struts. Smaller number = smaller free cell area.,Carotid WALLSTENTTM 頸動脈支架,支架設計-閉環(huán) Vs. 開環(huán),閉環(huán)支架設計Carotid WALLSTENT® EndoprosthesisXact® Carotid Stent開環(huán)支架設計Precise® PRO Rx Ni

5、tinol Stent SystemRX Acculink® Carotid Stent,Carotid WALLSTENT Endoprosthesis,Precise PRO Rx Nitinol Stent System,RX Acculink Carotid Stent,Images taken by and on file at BSC. Illustrations by BSC.,Precise Pro is

6、 a trademark of Cordis Corporation, Acculink is a trademark of Abbott Cardiovascular Systems, Inc, and Xact is trademark of MedNova, Ltd.,閉環(huán)支架設計,CWS與其他頸動脈支架相比，具有最小的支架網(wǎng)孔面積**,Carotid WALLSTENT® 閉環(huán)設計提供最大化的斑塊覆蓋以及光滑平整的管腔

7、,**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.

8、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.

9、Precise Pro is a trademark of Cordis Corporation, Acculink is a trademark of Abbott Cardiovascular Systems, Inc, and Xact is trademark of MedNova, Ltd.,*Free Cell Area: 測量支架連接小桿周長間的平均面積數(shù)值越小=支架網(wǎng)孔面積越小,Photographs taken b

10、y Boston Scientific Corporation,閉環(huán)支架設計,Carotid WALLSTENT® 閉環(huán)設計提供最大化的斑塊覆蓋以及光滑平整的管腔,Does Carotid Stent Design Influence Outcomes? R. M. Bersin, Catheterization and Cardiovascular Interventions 2008; 72:863–866,目前為止，已

11、經完成3項有關頸動脈支架設計與臨床結果的回顧性、非隨機研究。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 consist

12、ing of 3179 consecutive patientsSPACE, a retrospective, randomized trial of carotid artery stenting versus endarterectomy in standard surgical risk patients with symptomatic carotid artery stenosesSchillinger M, Gsch

13、wendtner M, Reimers B, et al. Does carotid stent cell design matter? A retrospective, nonrandomized review of a carotid artery stenting multicenter database consisting of 1,684 consecutive patients,Does Carotid Stent Des

14、ign Influence Outcomes? Bersin. Catheterization and Cardiovascular Interventions 2008; 72:863–866..,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;3

15、3:135-141.,目的: 明確頸動脈支架設計，尤其是支架網(wǎng)孔面積，對于頸動脈支架術后30天卒中、死亡或TIA的影響。30天結果的回顧性分析TIA，死亡, 大和小卒中(非心肌梗死)共3179接受頸動脈支架手術的患者4個中心Bosiers, Deloose - BelgiumPeeters, Verbis - BelgiumSetacci, Donato et al. - ItalyCremonesi, Castr

16、iota - Italy,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? Bosier

17、s et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,閉環(huán)支架定義為支架網(wǎng)孔面積 5.0mm2例如Precise® Rx Nitinol Stent SystemRX Acculink® Carotid Stent,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosi

18、ers 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：閉環(huán) vs. 開環(huán)支架設

19、計TIA, 死亡, 大和小卒中,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,對于癥狀性患者，術后第30天的主要事件發(fā)生率差異顯著開環(huán)支架設計(7.0%) VS 閉環(huán)支架設計(2.2%) (p<0.0001),Doe

20、s 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=1317P<0.0001,N=1862P=1.0,Does Free Cell Area Influence the Outcome in

21、Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,術后=(TIA, 卒中, 死亡) 直到術后30天發(fā)生閉環(huán) vs. 開環(huán)支架設計,Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vas

22、c Endovasc Surg 2007;33:135-141.,對于癥狀性患者，手術30天以后的主要事件發(fā)生率差異顯著開環(huán)支架設計(6.3%) VS 閉環(huán)支架設計(1.3%) (p<0.0001),N=3179P<0.0001,N=1317P<0.0001,N=1862P=1.0,患者評估由獨立神經病學醫(yī)師進行神經學上的局限性回顧性的研究非隨機設計可能導致在選擇時會因特定病變類型有所偏向注冊

23、數(shù)據(jù)受制于自我審計技術復雜性沒有評估，結果沒有經過風險校正有必要進行前瞻性的隨機研究來比較不同支架網(wǎng)孔面積以得到最終結論,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 Influenc

24、e the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,總結,四個中心的30天結果回顧性分析N=3179 CAS patients對于癥狀性患者，術后第30天的主要事件發(fā)生率差異顯著，開環(huán)支架設計(7.0%) VS 閉環(huán)支架設計(2.2%) (p<0.0001)對于癥狀性患者，

25、手術30天以后的主要事件發(fā)生率差異顯著，開環(huán)支架設計(6.3%) VS 閉環(huán)支架設計(1.3%) (p<0.0001),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 Influenc

26、e the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141.,Carotid WALLSTENT® Endoprosthesis,閉環(huán)設計跟蹤性極佳的SDS-支架輸送系統(tǒng)卓越的顯影性獨特的可回收能力* 唯一經FDA批準可用于雙側治療頸動脈支架**臨床數(shù)據(jù)支持,*Please n

27、ote 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 eligib

28、le patients with ipsilateral or bilateral carotid artery disease,跟蹤性極佳的SDS-支架輸送系統(tǒng),獨特的編織結構提高支架的柔順性,Carotid WALLSTENT®具有高度柔順的輸送系統(tǒng)，提供卓越的跟蹤性以通過扭曲病變,Testing performed on Carotid WALLSTENT Endoprosthesis 8mm x 21mm, Preci

29、se 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 deemed most typically selected for place

30、ment 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

31、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 for

32、ce required,低外廓的輸送系統(tǒng),匹配的導引鞘* (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 tradem

33、ark of MedNova, Ltd.,低外廓設計允許其通過5F or 6F血管鞘,Carotid WALLSTENT®的低外廓支架輸送系統(tǒng)使其具有卓越的跟蹤性以通過迂曲的解剖結構,便于使用,The pin-and-pull delivery systemis designed to simplify delivery,Carotid WALLSTENT® Endoprosthesis Delivery Sys

34、tem Final Assembly. Image property of Boston Scientific Corporation. Not necessarily to scale.,閉環(huán)設計跟蹤性極佳的SDS-支架輸送系統(tǒng)卓越的顯影性獨特的可回收能力* 唯一經FDA批準可用于雙側治療頸動脈支架**臨床數(shù)據(jù)支持,*Please note that reconstrainment and repositioning are

35、 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 caro

36、tid artery disease,Carotid WALLSTENTTM 頸動脈支架,出色的顯影性,在對比測試中，與其他頸動脈支架相比，Carotid WALLSTENT是顯影性最好的支架,Carotid WALLSTENT®的設計使支架具有高度可視性，便于支架的精確釋放,Testing performed on CarotidWALLSTENT Endoprosthesis 8mm x 21mm, Precise Pro

37、 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 deemed most typically selected for placement i

38、n 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 Abb

39、ott Cardiovascular 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 Illustrate

40、s the in vivo visibility of Carotid WALLSTENT and the Rx Acculink Carotid stent. May not be indicative of clinical performance.,. Acculink is a trademark of Abbott Cardiovascular Systems, Inc,,Carotid WALLSTENT® E

41、ndoprosthesis,RX Acculink® Carotid Stent,出色的顯影性,出色的顯影性,,Distal Inner RO Marker,Outer Distal RO Marker,,,All Photographs taken by Boston Scientific Corporation,內桿及外鞘上的可回收標記點均不透射線，幫助支架的定位,閉環(huán)設計跟蹤性極佳的SDS-支架輸送系統(tǒng)卓越的顯影性

42、獨特的可回收能力* 唯一經FDA批準可用于雙側治療頸動脈支架**臨床數(shù)據(jù)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 WALL

43、STENT Endoprosthesis is indicated for use in eligible patients with ipsilateral or bilateral carotid artery disease,Carotid WALLSTENTTM 頸動脈支架,獨特的可回收能力*,*Please note that reconstrainment and repositioning are subject to s

44、pecific limitations. Please refer to DFU cautions and warnings for additional information.,CarotidWALLSTENT®的獨特設計使其可以重新回收再釋放，幫助支架的精確釋放,獨特的導管結構和支架設計使支架在其在釋放少于50%時都可以回收再釋放,DFU中與回收相關的注意事項*:只有在必要時才進行回收 當支架已解除斑塊時，應該嚴格

45、避免回收回收次數(shù)不能超過2次,不可回收標記點,Carotid WALLSTENT® Endoprosthesis Delivery System Final Assembly. Image property of Boston Scientific Corporation. Not necessarily to scale.,*Please note that reconstrainment and repositionin

46、g are subject to specific limitations. Please refer to DFU cautions and warnings for additional information.,獨特的可回收能力*,顯示支架回縮的“不可回收點”只要外鞘的回撤未超過不可回收標記點，醫(yī)生都可以對支架進行回收重新釋放（不超過2次，未接觸斑塊）,,閉環(huán)設計跟蹤性極佳的SDS-支架輸送系統(tǒng)卓越的顯影性獨特的可回收能

47、力* 唯一經FDA批準可用于雙側治療頸動脈支架**臨床數(shù)據(jù)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 En

48、doprosthesis is indicated for use in eligible patients with ipsilateral or bilateral carotid artery disease,Carotid WALLSTENTTM 頸動脈支架,閉環(huán)設計跟蹤性極佳的SDS-支架輸送系統(tǒng)卓越的顯影性獨特的可回收能力* 唯一經FDA批準可用于雙側治療頸動脈支架**臨床數(shù)據(jù)支持,*Please note tha

49、t 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 pati

50、ents with ipsilateral or bilateral carotid artery disease,Carotid WALLSTENTTM 頸動脈支架,28,尺寸的正確選擇,Carotid WALLSTENTTM 頸動脈支架,Carotid WALLSTENT® Monorail®,Carotid Wallstent的尺寸選擇,選擇Wallstent 根據(jù):靶血管的最大直徑支架植入部位的長度,

51、Wallstent的完全釋放直徑要比靶血管的最大直徑 至少大1 mm支架覆蓋病變兩側的正常組織，至少各長5 mm,,尺寸選擇原則,Carotid Wallstent尺寸選擇,32,支架直徑 = 血管直徑 (a) + 1 or 2 mm支架長度 (b) = 病變長度 (c) + 10 mm (兩側各超出5mm),33,,30 mm,8 mm,5.4 mm,應選擇何種直徑的Carotid Wallsetent?,9 mm,40 mm,