GORE EXCLUDER AAA Endoprosthesis Stent Graft W.L

Aortic Extender Endoprosthesis and Iliac Extender Endoprosthesis Components Aortic Extender Endoprosthesis The Aortic Extender Endoprosthesis (Aortic Extender) provides an extension of approximately 1.6 cm or 2.2 cm of the leading (proximal) end of the Trunk- Ipsilateral Leg Endoprosthesis (Trunk). The Aortic Extender can be placed at variable extension lengths from 0 cm to 1.6 or 2.2 cm of the leading (proximal) end of the Trunk-Ipsilateral Leg Endoprosthesis (Trunk), allowing customization of extender treatment length based on patient anatomy and physician preference. This extension requires a minimum of approximately 1.6 cm or 2.2 cm overlap with the Trunk. The graft material is expanded polytetrafluoroethylene and fluorinated ethylene propylene (eptfe and FEP), and is supported by nitinol (nickel titanium alloy) wire along its external surface. An eptfe / FEP sealing cuff is located near the proximal end of the endoprosthesis (Figure 4). An eptfe / FEP sleeve is used to constrain the endoprosthesis on the leading end of the delivery catheter (Figures 5A and 5B). Deployment of the Aortic Extender initiates from the trailing (trunk) end and proceeds toward the leading (aortic) end of the endoprosthesis and delivery catheter. Following deployment, the eptfe / FEP sleeve remains in situ between the endoprosthesis and the vessel wall. Figure 4: Aortic Extender Endoprosthesis* s (3 Long) Sealing Cuff (1 Short) 3.3 or 4.5 cm Aortic Extender s (4 total): Three (3) long markers at the proximal or top end One (1) short marker at the distal or bottom end * Note: All dimensions are nominal. Figure 5A: Aortic Extender Endoprosthesis Delivery Catheter LEADING END TRAILING END Deployment Tuohy-Borst Knob Valve Light-Colored Shaft Constrained Endoprosthesis Flushing Port Figure 5B: Constrained Aortic Extender Endoprosthesis LEADING END Long s (3) Guidewire Lumen Figure 6A: Iliac Extender Endoprosthesis* (1) (1) (1) 3 cm 7 cm Iliac Extender s (3 total): Two (2) end markers: one (1) at each end One (1) marker located 3 cm below the proximal end * Note: All dimensions are nominal. Figure 6B: Constrained Iliac Extender Endoprosthesis (Distal Iliac Diameters of 10, 12, and 14.5 mm) LEADING END on Delivery Catheter Contralateral Leg Endoprosthesis Used as Iliac Extender Endoprosthesis (Distal Iliac Diameters of 16, 18, and 20 mm) Only Contralateral Leg Endoprostheses described in Figure 2B may also be utilized as Iliac Extenders as depicted in Figure 7. A minimum overlap of 3 cm between the original Ipsilateral Leg (Figure 7A) or Contralateral Leg (Figure 7B and 7C) is required. A radiopaque marker located 3 cm below the proximal end is provided to confirm this overlap. This overlap should be achieved prior to the beginning of the distal taper zone of the 18 and 20 mm Contralateral Leg. Further, the distal end including the taper zone should not be deployed inside the previously deployed Ipsilateral Leg or Contralateral Leg of the GORE EXCLUDER AAA Endoprosthesis if the distal end diameters are 12 or 14.5 mm. A radiopaque marker located 4 cm above the distal end defines the recommended minimal extension required of the Contralateral Leg as an Iliac Extender. However, when the Contralateral Leg and Iliac Extender diameters are identical, the taper zone can be deployed inside the previously deployed Contralateral Leg (Figure 7B). Figure 7: Contralateral Leg Endoprosthesis as an Iliac Extender (Distal Iliac Diameters of 16, 18, and 20 mm) 7A 7B 7C on Delivery Catheter Iliac Extender Endoprosthesis (Distal Iliac Diameters of 10, 12, and 14.5 mm) The Iliac Extender Endoprosthesis (Iliac Extender) provides an extension of up to 4 cm of either the ipsilateral or contralateral limb. The extender component can be placed at variable extension lengths from 0 cm to 4 cm allowing customization of extender treatment length based on patient anatomy and physician preference. The graft material is eptfe / FEP, and is supported by nitinol wire along its external surface. A radiopaque marker is located 3 cm from the proximal or top end (Figure 6A). This marker denotes the recommended minimum overlap with the ipsilateral or contralateral limb of the GORE EXCLUDER AAA Endoprosthesis. An eptfe / FEP sleeve is used to constrain the endoprosthesis on the leading end of the delivery catheter (Figure 6B). Deployment of the Iliac Extender initiates from the leading (aortic) end and proceeds toward the trailing (iliac) end of the delivery catheter. Following deployment, the eptfe / FEP sleeve remains in situ between the endoprosthesis and the vessel wall Overlap zone must be at least 3 cm within host device. 2. Most distal Contralateral Leg may extend 0 to 4 cm from another 16, 18, or 20 mm Contralateral Leg. 3. Most distal Contralateral Leg should overlap at least 3 cm within host device

Gore | C3 EXCLUDER AAA Endoprosthesis

This study is being conduct to assess the safety and effectiveness of a Study Sevice,GORE® EXCLUDER® Conformable AAA Endoprosthesis, in patient's with an aneurysm in their abdominal aorta. In this research study, the Study Device will be placed inside the abdominal aorta (in the approximate area of the belly button) and the Study Device will extend into both leg arteries. The Study Device will block the aneurysm (the weakened and bulging part of the artery) in the abdominal aorta from blood flow while maintaining blood flow to the arteries in the legs. Information will be collected on the performance of the Study Device for up to five (5) years.


GORE EXCLUDER AAA Endoprosthesis | DAIC

Gore C3 EXCLUDER AAA Endoprosthesis - Independent Reviews by Clinicians for Clinicians

Gores low permeability EXCLUDER Endoprosthesis is composed of a durable, ePTFE graft, a low permeability film layer, ePTFE reinforcing film, an electropolished nitinol stent, and bonding film for stent to graft attachment.