SOLITAIRE颅内支架（行业特制）

1、75646 (A) DEC/07“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” 颅内支架概览颅内支架分类33颅内辅助支架的作用问题：宽的瘤颈使得动脉瘤内的弹簧圈容易移位或部分脱出到载瘤动脉里，这可能造成严重的并发症。解决方案：颅内辅助支架主要用于辅助宽颈动脉瘤的弹簧圈栓塞，防止弹簧圈的移位或部分脱出。44支架的基础知识与常用术语6开环 vs. 闭环闭环设计开环设计“游离” 的尖端67颅内支架不同的网眼设计Solitaire

2、 AB -闭环Leo Plus 闭环Neuroform 开环Enterprise 闭环未连接点78输送性和可回收性输送性：支架能够被输送到病变部位的能力，尤其是通过远端病变或通过迂曲的解剖结构的能力。可回收性：支架被释放后，可以被重新收回且被重新放置到更优位置的能力。这是一项非常重要的能力，分为完全回收和部分回收。8柔软性Flexibility为柔软性，支架在闭合状态下随血管的弯曲而弯曲的能力。柔软性越好，支架的通过性越佳。9910顺应性Comfortability，支架在打开状态下随血管的弯曲而弯曲的能力。 顺应性好，有利于支架完全贴壁和保持血管的正常生理弯曲。顺应性差可能导致血栓的形成10

3、11支架的贴壁性支架的贴壁性：支架与血管壁贴合的能力。贴壁性不好可能导致血栓和支架移位的发生11径向支撑力是支架对血管壁的支撑能力-决定支架对弹簧圈的支撑能力-衡量支架的稳定性和移位效应121213开环 vs. 闭环开环闭环Solitaire AB径向支撑力中/低高高柔软性/顺应性高低高打折和毛刺现象毛刺现象明显光滑光滑支架的结构性支撑好更好最优1314毛刺现象和打折现象毛刺现象：Gator-Backing，指支架被置于弯曲解剖处时，网丝向外扩张/伸出的趋势。类似鳄鱼背脊。打折现象：支架的弯曲能力，弯曲能力差支架容易在弯曲处发生打折现象，容易造成血管的闭塞1415支架短缩？支架释放/撑开前后轴

4、向上长度的差异所有支架都有一定程度的短缩取决于支架的材质和设计对支架的精确释放有重要的意义，但.如果支架可以完全回收重新放置， 4 mm 4 mm4041操作图示支架的回收和重新释放支架回收：保持支架位置不动，小心推送微导管，直到支架全部收到微导管里。SOLITAIRE AB可以完全回收2次。4142操作图示-填弹簧圈将微导管（远端头端 2.5F）通过支架网眼送入动脉瘤内，填圈。42解脱 使用NDS-2解脱盒CR00049 Rev.BNot available for sale in the United States解脱原理 Covidien | 09 July 2022 | Confide

5、ntial44 |Insertion Needle（钢针）Solitaire AB Detachment Zone（支架解脱点）解脱点的金属结构在外部电流到达、然后离开的过程中发生电解腐蚀。如Solitaire AB的电流途径是：电流从解脱盒发出，到达支架解脱点；支架解脱点发生电解腐蚀；然后电流通过导电途径到达钢针。完整的电流回路是解脱的必要条件)（虽然钢针也接收到电流，但是由于有一定的保护，所以结构上不会受到影响）促进电流运动的因素：盐水冲洗肌肉（+）（-）4445解脱盒参数电压(9V)电流1 mA按钮：StopStartOnTimer显示解脱过程正消耗的时间 (分.秒).最长解脱时间: 2

6、分钟CR00049 Rev.BNot available for sale in the United StatesThis is picture of NDS-14546配件连接线: -1副消毒针(20 G or 22 G)CR00049 Rev.BNot available for sale in the United States4647Detachment ZoneDetachment ZonePushWireIntroducerSheathTotal LengthUsable LengthDistal MarkersProximal MarkerInternal Use onlyFo

7、r ev3 Inc. Presentation Use Only Not for Distribution47 Electrolytic DetachmentCR00049 Rev.BNot available for sale in the United States4748准备和检测使用新电池:电池指示灯常亮：电量足够电池指示灯闪烁： 更换电池将连接线接头插到解脱盒上，并旋紧确保连好。打开开关On, 听到一短提示音检测：按 Stop钮，所有数字显示 8.CR00049 Rev.BNot available for sale in the United States4849患者与器械的连接患

8、者将消毒针插在肩膀(或腹股沟处)将“黑线”卡在钢针上。Solitaire将“红线”卡在支架推送导丝的近端无PTFE涂层处暴露解脱点（确保微导管未覆盖支架解脱点）。CR00049 Rev.BNot available for sale in the United States4950解脱按“Start”开始解脱电压框显示解脱电压(0.0 to 9.9 volts).如果电压显示0.0 伏, 可能有短路存在，请重新检查连接如解脱成功，则：解脱盒发出周期性重复的报警声“Detach” 灯常亮或解脱2分钟后，解脱盒发出周期性重复的报警声.ProductSolitaire ABSolitaire_AB.

9、exeCR00049 Rev.BNot available for sale in the United States50操作动画.ProductSolitaire ABSolitaire_AB.exe515152成功的支架释放Detached StentCR00049 Rev.BNot available for sale in the United States5253SOLITAIRE AB的输送与输送弹簧圈一样简便，最小使用ID 0.021”的微导管输送。柔软性好，易于通过迂曲的血管。使用简便支架应用5354支架应用Distal markersProximal marker辅助支撑弹簧

10、圈 贴壁性好 径向支撑力好 可视性佳54磁共振成像相容性 09 July 2022 | Confidential55 |55异议处理CR00049 Rev.BNot available for sale in the United States57防止填圈过程中支架解脱假阳性解脱（未解脱）假阴性解脱（解脱了）CR00049 Rev.BNot available for sale in the United States5758防止填圈过程中支架解脱如希望在填圈后解脱支架，则手术过程中可以:用微导管覆盖支架解脱点在解脱弹簧圈时，用干布覆盖推送导丝近端（体外）如果导丝交叉可能出现交叉电流，导致支架

11、过早解脱。避免推送导丝交叉干布覆盖支架推送导丝CR00049 Rev.BNot available for sale in the United States5859假阳性解脱（未解脱）解脱盒已经报警显示解脱，但实际上未解脱CR00049 Rev.BNot available for sale in the United States59解脱的优化方法：解脱前：消毒针插在患者肩膀或颈部。在针头处滴几滴生理盐水。消毒针插在肌肉层里。使用9V新电池。使用新电解线。6060优化方法：解脱中：确保微导管中持续快速滴注生理盐水避免消毒针插在脂肪层支架近端标记与微导管远端标记之间距离2mm支架推送导丝近端

12、在干燥的操作台表面确保卸掉微导管与支架推送导丝上的力量6161国外医生经验方法：针头处滴几滴生理盐水按Stop 重置，按Start 再次解脱换用BSC的解脱器626263假阴性释放（解脱了）医生看到支架解脱但解脱盒10秒后仍未报警 (解脱盒设定程序为解脱后5秒报警）:建议等待解脱时间至2分钟，透视下辨别CR00049 Rev.BNot available for sale in the United States63中断解脱CR00049 Rev.BNot available for sale in the United States65中断解脱并继续解脱按“STOP”可以中断“timer”停

13、止计时电流(0.0 mA) 和电压 (“-.-”) 被切断.重新开始请短按 ( will have to jail the catheterPotential of coil herniationComparison:Solitaire AB maintains better wall apposition than Enterprise and Neuroform9798Gator-BackingNeuroform3 3.5x20Leo 3.5x25Solitaire AB 4x20Enterprise 4.5x22Wingspan 3.5x159899KinkingSolitaire AB

14、 4x20Enterprise 4.5x22Leo 3.5x25Neuroform3 3.5x20Wingspan 3.5x1599100Gator-Backing and KinkingFor some physicians this is important, for others it is nice-to-know though wouldnt stop them from using a stent they like.Clinical relevance:May result in coil herniationUnlikely that kinking will result i

15、n vessel occlusion, though it might limit catheter accessComparison:Gator-backing and kinking not observed in Solitaire AB and Enterprise100101Stent Cell Area101102Stent Cell Size102103Cell area and sizePhysicians would like to know both dataClinical relevance:Want to know whole area for potential c

16、oil herniationThe size is important for catheter size to be able to go thruComparison:Able to place a 3 mm stent through Solitaire AB for bifurcation / Y-stenting, while other stents have much smaller cell sizeA catheter diameter of 3 mm can cross Solitaire, while a catheter diameter of 1.3 mm can c

17、ross the Enterprise.The largest catheter that can pass through in Solitaire is 8F. This is larger than most devices used in neurovascular intervention.Solitaire AB cell length is similar to Enterprise, though Solitaire is twice as wide, therefore cell area of Solitaire is twice as large.103104Workin

18、g area foreshorteningDeviceSize (mm)Foreshortening (%)Enterprise4.5 x 156.74. 5 x 227.74.5 x 289.84.5 x 3710.9Neuroform 34 x 205.4Solitaire AB4 x 2015.36 x 3018.1Working area of Solitaire AB does not foreshorten104105Delivery methodSolitaire AB:Device attached to pushwire, loaded into a sheath. Push

19、ed through entire catheter. Electrolytic detachment.Enterprise:Device is loaded into a sheath, loaded over the guidewire and pushed through the entire catheter. Device is released from the guidewire when released from the catheter.Neuroform and Wingspan:Device loaded over polymer tube and preloaded

20、at tip of catheter. Guidewire access through polymer tube. Device is released when catheter is pulled back.Leo:Device hooked onto pushwire, loaded into a sheath. Pushed through entire catheter. Device detaches when pushwire tip exits catheter and unhooks from device.105106Delivery methodClinical rel

21、evance:Solitaire AB is easy to use, delivers like a coil, no extra steps needed. Disadvantage is potential loss of guidewire access.Stent needs to be able to be delivered at the right placeComparison:Physicians will choose stents based on aneurysm size and location, stent and delivery characteristic

22、s. It is important to understand of your physician what he takes into configuration and how Solitaire will work in his practice.106Market Overview108Projected Market size108109Estimated Market Overview109110Outlook Solitaire ABPotential risks: Product availability Full range of sizes Flow Diversion1

23、10Stents and Balloons112StentsAdvantagesStraight forward and easy procedureSmall risk of coil herniationChoice between coiling thru the struts or jailing the catheter.Can put stent in a few days before coiling and let it endothelializeIf a loop pops out, you only have to pull out that specific coil1

24、12113StentsDisadvantagesPermanent foreign body in the brain, no long-term results available yetNeed life-time medication to minimize in-stent restenosis or thrombosisStent can jumpDifficulty deploying the stent in tortuous environmentSeveral stents might be necessary to cover the neck (stent in sten

25、t technique)Safety:Risk of catheter stuck in stent113114BalloonsAdvantagesPrevents misplacement of coils and reduces risk of ischemic eventsAfter procedure no foreign material remains in vesselSafety:No need to place catheter deep in AN for coil deliveryIn case of rupture, a placed balloon allows fo

26、r immediate hemorrhage controlAllows coverage of complex and difficult located wide neck aneurysmsUsually no meds needed (even though some physicians prefer to give Plavix and / or aspirin)114115Balloons Assisted Coiling HyperGlide/HyperFormDisadvantagesNo permanent barrierProcedure increases in com

27、plexity and durationTraining requiredNeed to control the inflation and deflationInstability, balloon can jumpBlood can re-enter the AN, increasing the pressure and leading to potential AN rupturingCan only see after balloon has been removed and all coils delivered, if a loop pops out. If so all coil

28、s will have to be pulled out.115116Strategic ImplicationsIts not (necessarily) an either / or storyStent or Balloon can be used in most casesEngage the discussion with your physician !Highlight benefits of both and how they can work complementary ACOMM : rarely treated w/o balloonPCOMM : balloon and

29、 stent work well 116117Key Messages“Fully deployable. Completely retrievable.”Ease in deliveryAccuracy and deployment controlOptimal coil mass supportElectrolytic detachment117118Sales ToolsAvailable Q1:BrochureCompetitive overviewIn-service presentationCase study bookletWebsiteTargeted in Q2:Wall c

30、hartCD with video on preparation, deployment and detachmentSales ContestBooth graphics118119Brochure, page 1119120Brochure, page 2120121121122122123Revenue objectives2008Revenue Units ASPAccounts2008 Fcst (Rev)Market share(Units)Europe$1,402,315424$3,30776117%9.5 %IDM$420,427270$1,55721138%5.2 %Tota

31、l$1,822,742694$2,62697121%7.2 %2009Revenue (AOP)Units ASPMarket share(Units)Europe$3,094,000941$3,288 18 %IDM$1,152,000752$1,53211.3 %Total$4,246,0001,693$2,50814 %123124Objectives 2009Increase awareness / drive adoption:PublicationsKOL managementUser meetingsPodium presenceMarketing materialsSales

32、trainingStart Registry124125KOLKOLs for Solitaire AB:Dr. BattacharyaDr. BoccardiProf. HenkesProf. KlischDr. LiebigProf. TurjmanKOL and User meetingsLINNC MayESMINTSeptemberPodium presentations:Val dIsereLINNCWFITNESMINTICS125126UK Case StudyBackground:Stent market was not very well developedBad experience with Neuroform and LeoEnterprise came in and took whole market126127UK Succes