We Catch What Others Miss
GORE Embolic Filter Diamond Frame Circumferential Filter Attachment eptfe Filter Media with 100-Micron Pores and Hydrophilic Heparin Coating
Diamond Frame designed to enhance wall apposition to improve filter efficiency. Circumferential Filter Attachment designed to limit the escape of debris between the frame and vessel wall while accommodating small landing zones with tight curves. eptfe Filter Media with 100-Micron Pores and Hydrophilic Heparin Coating along with proximal frame attachment provides large filter capacity and good flow through the filter. Trackability with torque response similar to bare wire. Access tight tortuous lesions.
IN VITRO EVALUATIONS * Filter Efficiency The ability to capture embolic debris is driven by a combination of filter frame vessel apposition, circumferential support of filter media and pore size the GORE Embolic Filter excels in all three. The GORE Embolic Filter maintains performance when deployed in tight curves that are representative of clinical anatomy. Pore Size (microns) GORE Embolic Filter 100 Boston Scientific FILTERWIRE EZ 110 Abbott RX ACCUNET 120 Cordis ANGIOGUARD RX 100 Covidien SPIDERFX 50 300 Abbott Vascular EMBOSHIELD NAV6 120 1000 Average capture efficiency and normalized pressure gradient increase with 143 μm particles (n = 10) Normalized Pressure Gradient Increase with 143 µm particles (%) 900 800 700 600 500 400 300 200 Cordis 100 ANGIOGUARD Abbott RX ACCUNET RX Covidien SPIDERFX 0 0 10 20 30 40 50 Abbott Vascular EMBOSHIELD NAV6 Boston Scientific FILTERWIRE EZ GORE Embolic Filter 60 70 80 90 100 Capture Efficiency (%) * Siewiorek GM, Wholey MH, Finol EA. A comparative analysis of bench-top performance assessment of distal protection filters in transient flow conditions. Journal of Endovascular Therapy 2012;19(2):249-260.
Lesion Crossability TIP TRANSITIONS Smooth tip transition may reduce potential for embolization while crossing lesions. 3.2 Fr crossing profile is competitive with other devices. GORE Embolic Filter Boston Scientific FILTERWIRE EZ Abbott RX ACCUNET Cordis ANGIOGUARD RX Covidien SPIDERFX Abbott Vascular EMBOSHIELD NAV6 GORE Embolic Filter 0.014" Guidewire Nitinol frame Heparin-coated eptfe with 3 radiopaque filter bag markers Olive Floppy tip (radiopaque) Radiopaque Collar 3 cm Delivery Catheter 150 cm Wire Exit Port 30 cm 3.2 Fr (1.1 mm) Retrieval Catheter 150 cm Radiopaque Marker 4.8 Fr (1.6 mm) Wire Exit Port 3 mm 30 cm
Particles Missed by Commercially-Available Filters Recent Filter Efficiency Publication Highlights * Independent verification of internal filter efficiency video GORE Embolic Filter has the highest capture efficiency of the main embolic filters with the smallest particles GORE Embolic Filter demonstrates excellent flow rates and minimal pressure gradients Embolic Debris missed by GORE Embolic Filter Embolic Debris missed by Abbott RX ACCUNET Embolic Debris missed by Boston Scientific FILTERWIRE EZ Embolic Debris missed by Abbott Vascular EMBOSHIELD NAV6 Embolic Debris missed by Cordis ANGIOGUARD RX Embolic Debris missed by Covidien SPIDERFX * Siewiorek GM, Wholey MH, Finol EA. A comparative analysis of bench-top performance assessment of distal protection filters in transient flow conditions. Journal of Endovascular Therapy 2012;19(2):249-260.
Configurations Catalogue Number (US / Europe) Filter Diameter Unconstrained (mm) Reference Vessel Diameter Range (mm) Description GEF A015185 / GEF E015185 5 2.5 4.0 5 mm Filter on 185 cm Guidewire GEF A015300 / GEF E015300 5 2.5 4.0 5 mm Filter on 300 cm Guidewire GEF A017185 / GEF E017185 7 4.0 5.5 7 mm Filter on 185 cm Guidewire GEF A017300 / GEF E017300 7 4.0 5.5 7 mm Filter on 300 cm Guidewire Sizing Table Filter Diameter Unconstrained (mm) Reference Vessel Diameter Range (mm) Guiding Catheter / Sheath 5.0 2.5 4.0 min ID 0.066" (1.67 mm) 7.0 4.0 5.5 min ID 0.066" (1.67 mm) 6 Fr guide catheter and 5 Fr sheath compatible
W. L. Gore & Associates, Inc. Flagstaff, AZ 86004 +65.67332882 (Asia Pacific) 00800.6334.4673 (Europe) 800.437.8181 (United States) 928.779.2771 (United States) goremedical.com INDICATIONS FOR USE IN THE US: The GORE Embolic Filter is indicated for use as a guidewire and embolic protection system to contain and remove embolic material during angioplasty and stenting procedures in carotid arteries with diameters between 2.5 and 5.5 mm. INDICATIONS FOR USE UNDER CE MARK: The GORE Embolic Filter is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus / debris) during angioplasty and stenting procedures in coronary arteries, saphenous vein grafts, carotid arteries and peripheral arteries with reference diameters of 2.5 to 5.5 mm. Refer to Instructions for Use at goremedical.com for a complete list of contraindications, warnings and precautions, and adverse events. Products listed may not be available in all markets. ACCUNET, EMBOSHIELD, and NAV6 are trademarks of the Abbott Laboratories. FILTERWIRE EZ is a trademark of Boston Scientific Corporation. ANGIOGUARD RX is a trademark of Cordis Corporation. SPIDERFX is a trademark of Covidien. GORE, PERFORMANCE BY DESIGN, and designs are trademarks of W. L. Gore & Associates. 2006, 2008 2011, 2013 W. L. Gore & Associates, Inc. AQ4426-EN2 NOVEMBER 2013