1、75646 (A) DEC/07“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” 顱內(nèi)支架概覽顱內(nèi)支架分類33顱內(nèi)輔助支架的作用問題：寬的瘤頸使得動(dòng)脈瘤內(nèi)的彈簧圈容易移位或部分脫出到載瘤動(dòng)脈里，這可能造成嚴(yán)重的并發(fā)癥。解決方案：顱內(nèi)輔助支架主要用于輔助寬頸動(dòng)脈瘤的彈簧圈栓塞，防止彈簧圈的移位或部分脫出。44支架的基礎(chǔ)知識(shí)與常用術(shù)語(yǔ)6開環(huán) vs. 閉環(huán)閉環(huán)設(shè)計(jì)開環(huán)設(shè)計(jì)“游離” 的尖端67顱內(nèi)支架不同的網(wǎng)眼設(shè)計(jì)Solitaire

2、 AB -閉環(huán)Leo Plus 閉環(huán)Neuroform 開環(huán)Enterprise 閉環(huán)未連接點(diǎn)78輸送性和可回收性輸送性：支架能夠被輸送到病變部位的能力，尤其是通過(guò)遠(yuǎn)端病變或通過(guò)迂曲的解剖結(jié)構(gòu)的能力。可回收性：支架被釋放后，可以被重新收回且被重新放置到更優(yōu)位置的能力。這是一項(xiàng)非常重要的能力，分為完全回收和部分回收。8柔軟性Flexibility為柔軟性，支架在閉合狀態(tài)下隨血管的彎曲而彎曲的能力。柔軟性越好，支架的通過(guò)性越佳。9910順應(yīng)性Comfortability，支架在打開狀態(tài)下隨血管的彎曲而彎曲的能力。 順應(yīng)性好，有利于支架完全貼壁和保持血管的正常生理彎曲。順應(yīng)性差可能導(dǎo)致血栓的形成10

3、11支架的貼壁性支架的貼壁性：支架與血管壁貼合的能力。貼壁性不好可能導(dǎo)致血栓和支架移位的發(fā)生11徑向支撐力是支架對(duì)血管壁的支撐能力-決定支架對(duì)彈簧圈的支撐能力-衡量支架的穩(wěn)定性和移位效應(yīng)121213開環(huán) vs. 閉環(huán)開環(huán)閉環(huán)Solitaire AB徑向支撐力中/低高高柔軟性/順應(yīng)性高低高打折和毛刺現(xiàn)象毛刺現(xiàn)象明顯光滑光滑支架的結(jié)構(gòu)性支撐好更好最優(yōu)1314毛刺現(xiàn)象和打折現(xiàn)象毛刺現(xiàn)象：Gator-Backing，指支架被置于彎曲解剖處時(shí)，網(wǎng)絲向外擴(kuò)張/伸出的趨勢(shì)。類似鱷魚背脊。打折現(xiàn)象：支架的彎曲能力，彎曲能力差支架容易在彎曲處發(fā)生打折現(xiàn)象，容易造成血管的閉塞1415支架短縮？支架釋放/撐開前后軸

4、向上長(zhǎng)度的差異所有支架都有一定程度的短縮取決于支架的材質(zhì)和設(shè)計(jì)對(duì)支架的精確釋放有重要的意義，但.如果支架可以完全回收重新放置， 4 mm 4 mm4041操作圖示支架的回收和重新釋放支架回收：保持支架位置不動(dòng)，小心推送微導(dǎo)管，直到支架全部收到微導(dǎo)管里。SOLITAIRE AB可以完全回收2次。4142操作圖示-填彈簧圈將微導(dǎo)管（遠(yuǎn)端頭端 2.5F）通過(guò)支架網(wǎng)眼送入動(dòng)脈瘤內(nèi)，填圈。42解脫 使用NDS-2解脫盒CR00049 Rev.BNot available for sale in the United States解脫原理 Covidien | 09 July 2022 | Confide

5、ntial44 |Insertion Needle（鋼針）Solitaire AB Detachment Zone（支架解脫點(diǎn)）解脫點(diǎn)的金屬結(jié)構(gòu)在外部電流到達(dá)、然后離開的過(guò)程中發(fā)生電解腐蝕。如Solitaire AB的電流途徑是：電流從解脫盒發(fā)出，到達(dá)支架解脫點(diǎn)；支架解脫點(diǎn)發(fā)生電解腐蝕；然后電流通過(guò)導(dǎo)電途徑到達(dá)鋼針。完整的電流回路是解脫的必要條件)（雖然鋼針也接收到電流，但是由于有一定的保護(hù)，所以結(jié)構(gòu)上不會(huì)受到影響）促進(jìn)電流運(yùn)動(dòng)的因素：鹽水沖洗肌肉（+）（-）4445解脫盒參數(shù)電壓(9V)電流1 mA按鈕：StopStartOnTimer顯示解脫過(guò)程正消耗的時(shí)間 (分.秒).最長(zhǎng)解脫時(shí)間: 2

6、分鐘CR00049 Rev.BNot available for sale in the United StatesThis is picture of NDS-14546配件連接線: -1副消毒針(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準(zhǔn)備和檢測(cè)使用新電池:電池指示燈常亮：電量足夠電池指示燈閃爍： 更換電池將連接線接頭插到解脫盒上，并旋緊確保連好。打開開關(guān)On, 聽到一短提示音檢測(cè)：按 Stop鈕，所有數(shù)字顯示 8.CR00049 Rev.BNot available for sale in the United States4849患者與器械的連接患

8、者將消毒針插在肩膀(或腹股溝處)將“黑線”卡在鋼針上。Solitaire將“紅線”卡在支架推送導(dǎo)絲的近端無(wú)PTFE涂層處暴露解脫點(diǎn)（確保微導(dǎo)管未覆蓋支架解脫點(diǎn)）。CR00049 Rev.BNot available for sale in the United States4950解脫按“Start”開始解脫電壓框顯示解脫電壓(0.0 to 9.9 volts).如果電壓顯示0.0 伏, 可能有短路存在，請(qǐng)重新檢查連接如解脫成功，則：解脫盒發(fā)出周期性重復(fù)的報(bào)警聲“Detach” 燈常亮或解脫2分鐘后，解脫盒發(fā)出周期性重復(fù)的報(bào)警聲.ProductSolitaire ABSolitaire_AB.

9、exeCR00049 Rev.BNot available for sale in the United States50操作動(dòng)畫.ProductSolitaire ABSolitaire_AB.exe515152成功的支架釋放Detached StentCR00049 Rev.BNot available for sale in the United States5253SOLITAIRE AB的輸送與輸送彈簧圈一樣簡(jiǎn)便，最小使用ID 0.021”的微導(dǎo)管輸送。柔軟性好，易于通過(guò)迂曲的血管。使用簡(jiǎn)便支架應(yīng)用5354支架應(yīng)用Distal markersProximal marker輔助支撐彈簧

10、圈 貼壁性好 徑向支撐力好 可視性佳54磁共振成像相容性 09 July 2022 | Confidential55 |55異議處理CR00049 Rev.BNot available for sale in the United States57防止填圈過(guò)程中支架解脫假陽(yáng)性解脫（未解脫）假陰性解脫（解脫了）CR00049 Rev.BNot available for sale in the United States5758防止填圈過(guò)程中支架解脫如希望在填圈后解脫支架，則手術(shù)過(guò)程中可以:用微導(dǎo)管覆蓋支架解脫點(diǎn)在解脫彈簧圈時(shí)，用干布覆蓋推送導(dǎo)絲近端（體外）如果導(dǎo)絲交叉可能出現(xiàn)交叉電流，導(dǎo)致支架

11、過(guò)早解脫。避免推送導(dǎo)絲交叉干布覆蓋支架推送導(dǎo)絲CR00049 Rev.BNot available for sale in the United States5859假陽(yáng)性解脫（未解脫）解脫盒已經(jīng)報(bào)警顯示解脫，但實(shí)際上未解脫CR00049 Rev.BNot available for sale in the United States59解脫的優(yōu)化方法：解脫前：消毒針插在患者肩膀或頸部。在針頭處滴幾滴生理鹽水。消毒針插在肌肉層里。使用9V新電池。使用新電解線。6060優(yōu)化方法：解脫中：確保微導(dǎo)管中持續(xù)快速滴注生理鹽水避免消毒針插在脂肪層支架近端標(biāo)記與微導(dǎo)管遠(yuǎn)端標(biāo)記之間距離2mm支架推送導(dǎo)絲近端

12、在干燥的操作臺(tái)表面確保卸掉微導(dǎo)管與支架推送導(dǎo)絲上的力量6161國(guó)外醫(yī)生經(jīng)驗(yàn)方法：針頭處滴幾滴生理鹽水按Stop 重置，按Start 再次解脫換用BSC的解脫器626263假陰性釋放（解脫了）醫(yī)生看到支架解脫但解脫盒10秒后仍未報(bào)警 (解脫盒設(shè)定程序?yàn)榻饷摵?秒報(bào)警）:建議等待解脫時(shí)間至2分鐘，透視下辨別CR00049 Rev.BNot available for sale in the United States63中斷解脫CR00049 Rev.BNot available for sale in the United States65中斷解脫并繼續(xù)解脫按“STOP”可以中斷“timer”停

13、止計(jì)時(shí)電流(0.0 mA) 和電壓 (“-.-”) 被切斷.重新開始請(qǐng)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