1、Vascular Protection Training,Advanced Clinical Training,1,學(xué)習(xí)交流PPT,The Product,Features and Intended Benefits,2,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection System,The FilterWire EZ System is BSCs second generation embolic protection filter. It incorporates a number of design changes from the FilterWire

2、EX System (First Generation System) intended to improve the effectiveness and ease of use. Europe September 2003 commercialization for SVG, native coronary, peripheral and carotid intervention Dominant market share (PV and CV) despite many other embolic protection filter competitors US August 2004 c

3、ommercialization for SVG intervention Increased market share and market penetration December 2006 510(k) approved for carotid indication,3,學(xué)習(xí)交流PPT,FilterWire EZSystem Components,FilterWire EZ 5.5mm System Protection Wire EZ Delivery Sheath EZ Retrieval Sheath Accessories(peel-away introducer, guide

4、wire torquer, valve dilator tool) FilterWire EZ Bent Tip Retrieval Sheath (available separately),4,學(xué)習(xí)交流PPT,FilterWire EZ SystemAccessories,Peel-away Introducer Sheath Used to prevent damage to the spring tip of the protection wire during system insertion into a rotating or fixed hemostasis valve.,Gu

5、ide Wire Torquer Intended to enhance the operators grip on the protection wire for steerability during delivery and to provide leverage during filter deployment and capture.,Valve Dilator Tool Used with a fixed hemostasis valve to minimize damage to the filter bag upon removal through the valve.,5,學(xué)

6、習(xí)交流PPT,FilterWire EZ System,PEBAX is a registered trademark of Atofina Corporation,Atraumatic 3 cm, platinum, spring coil tip with floppy flexibility Radiopaque to enhance visualization Shapeable to enhance steerability 6.0 mm PEBAX Nosecone Flexible transition from the spring tip to the delivery sh

7、eath for excellent overall deliverability Provides a pro that is designed to reduce the risk of debris embolization during system delivery,6,學(xué)習(xí)交流PPT,FilterWire EZ System,Polyurethane filter membrane with 110 micron pores Designed to captures debris and reduce the risk of embolic related events Inten

8、ded to permit continuous blood flow for patient safety and comfort Intended to permit continuous blood flow that allows contrast injections for visualization during the intervention,7,學(xué)習(xí)交流PPT,FilterWire EZ System,Conforming, nitinol filter loop with platinum coil Highly visible to guide filter place

9、ment and to ensure good vessel wall apposition One device that accommodates vessels with landing zone diameters ranging from 3.5mm to 5.5mm minimizes sizing guesswork and inventory needs Designed to provide continuous wall apposition around the circumference of the vessel lumen to minimize the oppor

10、tunity for debris to collect on the outside of the filter Automatically adjusts to changes in the vessel aperture,8,學(xué)習(xí)交流PPT,FilterWire EZ System,Filter loop suspension arm allows the filter loop to move independently from the wire for good vessel wall apposition in both straight and curved anatomy S

11、implifies the landing zone requirements by allowing use in both straight and curved vessels No need to take 2 angio views to assess filter apposition,9,學(xué)習(xí)交流PPT,FilterWire EZ System,Spinner tube underlying filter assembly Allows the wire to rotate independently from the delivery sheath for excellent

12、system steerability .032” OD Catheter stop Provides a barrier designed to prevent therapeutic devices from collapsing the filter frame Lightly visible to contribute to visualization for device positioning*,* Note: A 0.013” OD part 5mm proximal to the catheter stop may also be visible with some equip

13、ment. This part keeps the spinner tube in place, but lets catheter tips pass over.,10,學(xué)習(xí)交流PPT,FilterWire EZ System,0.014” Stainless steel wire body with PTFE coating Available in 190cm and 300cm wire lengths 190cm wire length is compatible with BSCs AddWire GuideWire Silicone coated on distal 15 cm

14、of device, delivery, and retrieval sheath. Designed to reduce the amount of force required to load the filter into the delivery sheath and deploy in the vessel,11,學(xué)習(xí)交流PPT,EZ Delivery Sheath,150 cm PEBAX Resin sheath with 100cm, peel-away exchange length The distal sheath changes color from blue to c

15、lear to serve as a warning that the non peel-away section at the end of the sheath is approaching 1.1mm (0.042” or 3.2F) Lesion crossing profile Distal end has a PTFE inner liner Internal stop loading feature alerts the operator that the filter is fully sheathed,12,學(xué)習(xí)交流PPT,EZ Retrieval Sheath,150cm

16、PEBAX Resin sheath with a 20cm long exchange length Soft distal tip Designed to facilitate the capability to cross deployed stents 1.4mm (0.056” or 4.3F) lesion crossing profile Internal stop capture feature Alerts the operator that the filter is fully captured,13,學(xué)習(xí)交流PPT,EZ Bent Tip Retrieval Sheat

17、h (sold separately),150cm PEBAX Resin sheath with a 20cm exchange length Bend at distal tip The bend is designed to aid in crossing stent struts that can complicate filter retrieval 1.3mm (0.052” or 4.0F) lesion crossing profile Internal stop capture feature Alerts the operator that the filter is fu

18、lly captured,14,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection System,Step-by-Step Instructions Product Demonstration,Please refer to the FilterWire EZ Embolic Protection System DFU for complete instructions for use.,15,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection System DFU available at,FilterWire EZ SystemD

19、FU Card,16,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection SystemPre-Procedure,Review the patients angiogram and determine if the vessel meets the requirements for safe and effective use of the FilterWire EZ System: The apex of the loop can be deployed a minimum of 3.0cm from the distal edge of the lesion.

20、 The vessel diameter at the desired location of the deployed filter loop is 3.5mm to 5.5mm. (2.25mm to 3.5mm for EZ Small),3.5mm 5.5mm vessel diameter,17,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection SystemPre-Procedure (continued),Prior to using the FilterWire EZ System, anticoagulate the patient to ach

21、ieve an ACT of 275 seconds for carotid applications and 300 seconds for SVG applications (200 seconds if GP IIb/IIIa inhibitors are used). In the absence of ACT measurement, administer an appropriate weight based bolus of heparin (approximately 125 units/kg).,18,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protect

22、ion SystemPre-Procedure (continued),RCA graft - most commonly used guide is the multipurpose. Marginal graft - Hockey stick guide is first choice followed by left Amplatz,LAD or Diagonal graft - most commonly used guides are the left Amplatz and Hockey stick.,Taken from Marco et.al.“Stenting of Dege

23、nerated Saphenous Vein Grafts” May 2001 Euro PCR,Based on vessel take-off, physician should consider which guide catheter shape will provide the best access and support.,19,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection System PREP: Delivery System,1.Open the pouch using sterile handling procedure and pla

24、ce the packaging coils and accessory kit into the sterile field. 2.Unclip and remove the yellow housing that protects the filter. Note: The protection wire is pre-loaded into the delivery sheath. 3.Detach the pre-loadedprotection wire from the retaining clip, advance the delivery sheath, then grasp

25、theclear section of the sheathand removesheathed wire from the coil.,FilterWire EZ System Product Packaging,20,學(xué)習(xí)交流PPT,4.Sheath the protection wire and filter by retracting the device into the EZ Delivery Sheath while the filter is immersed in heparinized saline.NOTE: Hold the Delivery sheath about

26、1cm proximal to the dark section. NOTE: Keep the filter unsheathed until immediately prior to use.,FilterWire EZ Embolic Protection System PREP: Delivery System (continued),3.Attach the wire torquer onto the proximal end of the protection wire.,Guide Wire Torquer,21,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Pro

27、tection SystemDelivery,2.Insert the FilterWire EZ System and peel-away introducer assembly into a guide catheter/ sheath. Once the FilterWire EZ System is inserted into the guiding catheter or guiding sheath, remove the peel-away introducer. NOTE: Use of a guiding catheter or a guiding sheath with a

28、 1.91mm (0.075”) or larger rotating hemostasis valve is recommended when performing a procedure with the FilterWire EZ System. The use of a sheath /guide catheter with a fixed hemostasis valve may cause the filter membrane to tear at the hemostasis valve upon removal.,1.Place the peel-away guide wir

29、e introducer over the tip of the delivery system (the spring tip of the system can be shaped as needed).,Peel-away Introducer Sheath,22,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection SystemDelivery (continued),3.To advance the FilterWire EZ System through the guiding catheter or guiding sheath, use a one-

30、handed technique advancing both the delivery sheath and protection wire together; this will prevent accidental deployment of the filter. 4.To steer the FilterWire EZ System to the target landing zone, use a two-handed technique, torquing the protection wire with one hand and advancing the delivery s

31、heath with the other hand. NOTE: For carotid interventions, having the patient turn their head to the left or right will change the orientation of the vessel and may facilitate device passage. NOTE: Consider using the buddy wire technique if the lesion is difficult to pass. Retract the buddy wire af

32、ter the lesion has been crossed by the FilterWire EZ System (If other efforts are unsuccessful, pre-dilatation can be used.),23,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection SystemDelivery (continued),5.Advance the FilterWire EZ System across the lesion until the apex of the filter loop can be deployed a

33、 minimum of 3.0cm distal to the lesion. NOTE: If an interventional device with a tip-to-shoulder length of greater than 10.0mm is to be used, a longer vessel length may be required to place the FilterWire EZ System in order to avoid contact between the filters catheter stop and the tip of the interv

34、entional device.,24,學(xué)習(xí)交流PPT,Once the protection wire is in place past the lesion, slide the torquer tip up to the hemostatic valve and tighten firmly. Deploy the filter by holding the protection wire with the torquer, then retracting and completely removing the delivery sheath. Be sure to keep the t

35、orquer in place as you peel-away the delivery sheath in a straight motion until the 3cm over-the-wire section is reached (see photo below).,FilterWire EZ Embolic Protection SystemFilter Deployment,Photograph taken by Boston Scientific Corporation,25,學(xué)習(xí)交流PPT,4.Once the delivery sheath is completely r

36、emoved, inject contrast and verify the device is in the proper position and there is adequate flow.NOTE: If repositioning is required, the EZ Retrieval Sheath should be used. Retract the protection wire and filter loop into the sheath, reposition the filter and redeploy. 5.Use the protection wire li

37、ke a traditional guide wire to track catheters and stent delivery systems to the target treatment area.,FilterWire EZ Embolic Protection SystemFilter Deployment (continued),26,學(xué)習(xí)交流PPT,1.Inject contrast frequently and always after any intervention or exchange, to visually verify that blood flow is no

38、t obstructed and that filter loop/vessel apposition to the vessel wall is maintained.CAUTION: If a filter becomes occluded during the procedure, remove it and deploy a second filter if further intervention is required. 2.Complete the procedure making sure the protection wire remains in the proper po

39、sition distal to the lesion (monitor fluoroscopy). Note: Failure to stabilize the protection wire could lead to inadvertent movement of the filter, resulting in protection wire entanglement and/or delay in the procedure.,FilterWire EZ Embolic Protection SystemDuring the Procedure,27,學(xué)習(xí)交流PPT,FilterWi

40、re EZ Embolic Protection SystemFilter Capture and Retrieval,1.Remove the EZ Retrieval Sheath from its packaging coil and flush with heparinized saline. 2.Advance the retrieval sheath over the protection wire past any deployed stents up to the proximal end of the filter loop.,Note: If the EZ Retrieva

41、l Sheath is not able to pass the deployed stent, be sure the stent is well apposed and consider post-dilitation. If the Retrieval Sheath is still unable to cross, try the EZ Bent Tip Retrieval Sheath (available separately).,EZ Bent Tip Retrieval Sheath Packaging,28,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Prot

42、ection SystemFilter Capture and Retrieval (continued),3.Gently and slowly retract the protection wire and filter loop back into the retrieval sheath until resistance is felt. 4.Observe the retrieval procedure under fluoroscopic imaging. Note: The distal edge of the collapsed filter loop should align

43、 with (see figure B), or be proximal to (figure A), the retrieval sheath marker band.,Retrieval Sheath Marker Band,A,B,29,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection SystemFilter Capture and Retrieval (continued),NOTE: If resistance is felt before the distal edge of the collapsed filter loop is aligned

44、 with the marker band, it is possible that there is a large amount of embolic debris in the filter. Carefully retract the protection wire and EZ Retrieval Sheath as a system. The distal part of the filter bag will be outside of the sheath during retrieval in this case; however, the filter loop must

45、be pulled fully into the sheath.,Fully Retracted Filter,Large Debris Load in Filter,30,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection SystemFilter Capture and Retrieval (continued),5.If any resistance is met during retraction of the sheathed FilterWire EZ System, slightly advance the sheathed FilterWire E

46、Z System and rotate the sheath before continuing to retract. 6.Slowly and carefully retract the entire system until the tip of the retrieval sheath is adjacent to the tip of the guiding catheter or guiding sheath. 7.If there is any resistance, retract the guiding catheter and FilterWire EZ System to

47、gether. This is done in case there is a large amount of embolic material captured in the filter that may not fit inside the guiding catheter.,31,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection SystemFilter Capture and Retrieval (continued),8. Remove the FilterWire EZ System from the patient. NOTE: When usi

48、ng a rotating hemostasis valve, ensure that the hemostasis valve is fully opened prior to FilterWire EZ System removal. CAUTION: If a guide sheath with a fixed hemostasis valve is used, the valve dilator tool is required for FilterWire EZ System removal. Removing the FilterWire EZ System through a f

49、ixed hemostasis valve without the use of a valve dilator may cause the filter membrane to tear. 9. If a fixed hemostasis valve is used, place the valve dilator (if provided in the accessory kit) on the shaft of the retrieval sheath and slide the tool into the valve. Then remove the FilterWire EZ Sys

50、tem from the patient through the valve dilator tool and remove the dilator.,32,學(xué)習(xí)交流PPT,Stent Entanglement,Potential for a distal embolic protection filter to entangle with a stent is inherent to interventional procedures using these devices.,SAFE PRACTICE FOR DISTAL PROTECTION FILTERS: Achieve good

51、guide catheter or guide sheath support Ensure sufficient landing zone Keep the filter in place during deployment Minimize wire movement during the procedure Achieve full stent apposition,33,學(xué)習(xí)交流PPT,FilterWire EZ Embolic Protection SystemTips for Use,34,學(xué)習(xí)交流PPT,Competition,RX ACCUNET (Abbott) Angiogu

52、ard (Cordis) Emboshield System (Abbott) Spider (ev3),35,學(xué)習(xí)交流PPT,CompetitionFixed Wire Filters,Sheathed Fixed Wire Devices: FilterWire EZ System, RX Accunet, Characteristics Filter attached to a proprietary wire Delivery sheath required,Photo by Boston Scientific,36,學(xué)習(xí)交流PPT,CompetitionWire of Choice

53、Filters,Wire of Choice Device: SpiderFX Device, Emboshield Characteristics: Use any .014” wire to gain access Deliver sheathed filter and proprietary guide wire over the wire of choice, then remove wire of choice Wire can move slightly (8mm of longitudinal “play”) without moving filter CANNOT remove

54、/replace deployed filter while maintaining access,SpideRX ,37,學(xué)習(xí)交流PPT,CompetitionOcclusive Devices,Distal Occlusion Device: Medtronic GuardWire System Characteristics: Proprietary wire with balloon attached Low crossing profile Balloon inflated distal to lesion Short landing zone Aspirate to remove

55、emboli Proximal Occlusion Devices: St. Jude Proxis System Characteristics Occlusive protection prior to crossing lesion Proxis stops flow and then aspirates to remove emboli,Proxis,GuardWire,38,學(xué)習(xí)交流PPT,Image by Boston Scientific Corp.,Abbott Vascular Devices,RX ACCUNET Embolic Protection System,39,學(xué)

56、習(xí)交流PPT,CompetitionRX ACCUNET System,Delivery,Retrieval,Filter Bag,Delivery method: Sheathed wire,Images by Boston Scientific Corp.,40,學(xué)習(xí)交流PPT,CompetitionRX ACCUNET System,Technical specs excerpted from RX ACCUNET System Directions for Use and other literature published by Abbott Vascular at as of Ma

57、rch 10, 2008,41,學(xué)習(xí)交流PPT,CompetitionRX ACCUNET System,Information excerpted from FilterWire EZ System and RX ACCUNET System Directions for Use and other literature published by Abbott Vascular at as of March 10, 2008,42,學(xué)習(xí)交流PPT,Excellent Deliverability Guide wire and delivery sheath enter vessel as o

58、ne unit Highly flexible to navigate tortuous anatomy Low pro smooth transition from tip to filter basket .014” wire is torqued independent from filter basket Accurate Deployment Rapid exchange unsheathing for stability and simplicity Peel away delivery sheath allows for controlled deployment Capture

59、 and Control for Optimal Protection Highly flexible filter basket designed to conform to tortuosity Designed to capture high volume while allowing adequate blood flow Concentric design with guide wire centered in filter Four platinum radiopaque markers surround filter for visualization of wall apposition Secure Filter Retrieval Choice of two rapid exchange recovery catheters designed specifically for the challenges of filter recovery. RX ACCUNET Recovery Catheter Shapeable distal tip steers catheter from stent struts during advancement Filter basket secured with all ca