【正文】 at protects the filter. Note: The protection wire is preloaded into the delivery sheath. the preloaded protection wire from the retaining clip, advance the delivery sheath, then grasp the clear section of the sheath and remove sheathed wire from the coil. FilterWire EZ? System Product Packaging Confidential For Internal Use Only Do Not Copy or Distribute. 21 of 128 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 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) the wire torquer onto the proximal end of the protection wire. Guide Wire Torquer Confidential For Internal Use Only Do Not Copy or Distribute. 22 of 128 FilterWire EZ? Embolic Protection System Delivery the FilterWire EZ System and peelaway introducer assembly into a guide catheter/ sheath. Once the FilterWire EZ System is inserted into the guiding catheter or guiding sheath, remove the peelaway introducer. NOTE: Use of a guiding catheter or a guiding sheath with a (”) or larger rotating hemostasis valve is remended 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. the peelaway guide wire introducer over the tip of the delivery system (the spring tip of the system can be shaped as needed). Peelaway Introducer Sheath Confidential For Internal Use Only Do Not Copy or Distribute. 23 of 128 FilterWire EZ? Embolic Protection System Delivery (continued) advance the FilterWire EZ System through the guiding catheter or guiding sheath, use a onehanded technique advancing both the delivery sheath and protection wire together。 System (Abbott) Spider (ev3) Confidential For Internal Use Only Do Not Copy or Distribute. 36 of 128 Competition Fixed Wire Filters ‘Sheathed Fixed Wire’ ? Devices: FilterWire EZ? System, RX Accu 174。 System ? Characteristics: – Proprietary wire with balloon attached – Low crossing profile – Balloon inflated distal to lesion – Short landing zone – Aspirate to remove emboli Proximal Occlusion ? Devices: St. Jude Proxis174。 Embolic Protection System Confidential For Internal Use Only Do Not Copy or Distribute. 40 of 128 Competition RX ACCUNET174。 Distal Tip cm cm Vessel Diameter Coverage – mm – mm (4 sizes – ,) Pore Size 110 micron Ranges up to 150 micron Device Wire Characteristics Moderate support Extra support Landing Zone cm cm Apposition Check 1 view 2 views Retrieval Sheath Profile Wire Lengths 190 cm, 300 cm 190 cm, 300 cm Guide Catheter Req. 6F (min ID ”) 8F (min ID ”) Indications Carotid, SVG Carotid 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, 2022 Confidential For Internal Use Only Do Not Copy or Distribute. 43 of 128 Excellent Deliverability ? Guide wire and delivery sheath enter vessel as one unit ? Highly flexible to navigate tortuous anatomy ? Low profile and 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 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 cage strut openings enclosed during withdrawal ? RX ACCUNET 2 Recovery Catheter – Lowprofile, flexible tip to allow for deflection away from stent struts during advancement – Flexible catheter/shaft optimized for challenging guide catheter/sheath access – Catheter shaft markers at 95 and 105 cm for reduced flouro time Competition RX ACCUNET174。 Rapid Exchange Embolic Protection System Confidential For Internal Use Only Do Not Copy or Distribute. 46 of 128 Competition Emboshield174。 System BareWire Technical specs excerpted from Emboshield System Directions for Use and other literature published by Abbott Vascular and made available at as of March 10, 2022 Confidential For Internal Use Only Do Not Copy or Distribute. 48 of 128 Competition Emboshield174。 System Perceived Strengths Perceived Weaknesses ? Ability to cross tight lesions using a relatively simple system (provided guidewire with ” stop) ? Low capture efficiency on a bend1 ? Ability to retrieve the filter while leaving the wire in place. ? Significant force is required to deliver the device2 ? Multiple sizes with vessel coverage of to mm diameter ? Limited radiopacity ? Requires crossing the lesion twice prior to protection – first with BareWire and then w/delivery catheter ? Increased procedural time ? Large landing zone required Images by Boston Scientific Corp. Confidential For Internal Use Only Do Not Copy or Distribute. 50 of 128 Information on Emboshield System excerpted from literature published by Abbott Vascular and made available at as of March 10, 2022 Competition Emboshield1