【正文】 190 cm device coined to allow for attachment to a “DOC” wire extension. ? The system is 6F sheath/8F guide catheter patible and has filters available in , , , and mm basket diameters that are remended for use in arteries ranging from mm to mm. ? The RX ACCUNET System?s flexible cage design assists in maintaining excellent wall apposition in pulsed flow environments and challenging anatomies. The RX ACCUNET System?s peel away delivery sheath allows for simple deployment with rapid exchange unsheathing for stability and ease of use. Additionally, the .014” wire can be torqued independently from the filter basket in order to help manage the navigation of tortuous anatomy. ? Recovery is performed with a choice of two dedicated RX recovery catheters. The original RX ACCUNET Recovery Catheter has a shapeable distal tip designed to offer steering control during advancement. The RX ACCUNET 2 Recovery Catheter is lower profile and more flexible and was designed to access more tortuous anatomies without catching on stent struts. Competition RX ACCUNET174。 System Positioning Information on RX ACCUNET System excerpted from literature published by Abbott Vascular and made available at as of March 10, 2022 Confidential For Internal Use Only Do Not Copy or Distribute. 45 of 128 Image by Boston Scientific Corp. Abbott Vascular Devices Emboshield174。 BareWire174。 Rapid Exchange Embolic Protection System Confidential For Internal Use Only Do Not Copy or Distribute. 46 of 128 Competition Emboshield174。 System Delivery method: BareWire174。 Device / wire first Cross lesion with provided BareWire Device, then advance Filter Delivery Catheter over BareWire Device to deployment site (note: the filter can only be positioned proximal to the ” step on the BareWire Device) Delivery Retrieval Filter Bag Images by Boston Scientific Corp. Information excerpted from Emboshield System DFU. Confidential For Internal Use Only Do Not Copy or Distribute. 47 of 128 Competition Emboshield174。 System Filter Diameter Vessel Size Range Crossing Profile mm mm mm mm mm mm mm – mm Support Level Length (cm) Soft 190, 315 Medium 190, 315 Extra 190, 315 Super 190, 315 Maximum 190, 315 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 FilterWire EZ System Emboshield System Delivery Method Sheathed filter wire BareWire174。 Device / wire first Crossing Profile amp。 Distal Tip cm cm Vessel Diameter Coverage – – mm (4 sizes – 3,4,5,6) Pore Size 110 micron 140 micron Device Wire Characteristics Moderate support 5 support levels (soft, medium, extra, super, maximum) Landing Zone cm – cm Apposition Check 1 view 2 views Retrieval Sheath Profile Wire Lengths 190 cm, 300 cm 190 cm, 315 cm Guide Catheter Req. 6F (min ID ”) 7F Indications Carotid, SVG Carotid Information excerpted from FilterWire EZ System and Emboshield System Directions for Use and other literature published by Abbott Vascular and available at As of March 10, 2022. Confidential For Internal Use Only Do Not Copy or Distribute. 49 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 Emboshield174。 System Positioning Designed for Choice, Safety, Confidence With the BareWire174。 Device, the wire crosses the lesion first, independent of the filter and delivery catheter. All other actions, including filter placement and retrieval, balloon dilatations, and stent placement then occur over the wire. CHOICE ? Five Different Wire Support Levels – Each available in two lengths offer lesionspecific access and support – The Super support BareWire Device is packaged with the Emboshield System SAFETY ? Optimized Fit of Retrieval Catheter to Wire – Snug fit of catheter tip to wire enhances trackability and reduces the likelihood of catching on the stent. ? Complete Filter Encapsulation for the secure removal of debris – Emboshield System enables plete retrieval for the secure removal of debris CONFIDENCE Support Level Soft Medium Extra Super Maximum Confidential For Internal Use Only Do Not Copy or Distribute. 51 of 128 SpiderFX Device picture excerpted from literature published by eV3 and made available at as of March 10, 2022 ev3 SpiderFX174。 Embolic Protection Device Confidential For Internal Use Only Do Not Copy or Distribute. 52 of 128 Filter Bag: Note the nitinol filter mesh pore size varies distal to proximal. Guidewire: Note the delivery sheath does not have a “nosecone” thus the leading edge is blunt vs. tapered. Delivery: Note the filter sits just behind the rapid exchange port during delivery over the previously placed guide wire. That wire is removed once the filter system is delivered past the lesi