Catalogue Numbers for GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System
Trunk - Ipsilateral Leg Endoprosthesis | |||||||
|---|---|---|---|---|---|---|---|
Catalogue Number | Intended aortic vessel diameter (mm) | Aortic Endoprosthesis | Length to flow divider (cm) | Intended iliac vessel diameter (mm) | Iliac Endoprosthesis | Overall device length (cm) | Recommended introducer sheath (Fr) |
| CXT201212E | 16–18 | 20 | 5.5 | 10–11 | 12 | 12 | 15 |
| CXT201412E | 16–18 | 20 | 5.5 | 12–13.5 | 14.5 | 12 | 15 |
| CXT231412E | 19–21 | 23 | 5.5 | 12–13.5 | 14.5 | 12 | 15 |
| CXT261412E | 22–23 | 26 | 5.5 | 12–13.5 | 14.5 | 12 | 16 |
| CXT281412E | 24–26 | 28.5 | 5.5 | 12–13.5 | 14.5 | 12 | 16 |
| CXT321414E | 27–29 | 32 | 6.5 | 12–13.5 | 14.5 | 14 | 18 |
| CXT361414E | 30–32 | 36 | 6.5 | 12–13.5 | 14.5 | 14 | 18 |
Aortic Extender Endoprosthesis | ||||
|---|---|---|---|---|
| Catalogue Number | Intended aortic vessel diameter (mm) | Endoprosthesis diameter (mm) | Endoprosthesis length (cm) | Recommended introducer sheath (Fr) |
| CXA200005E | 16–18 | 20 | 4.5 | 15 |
| CXA230005E | 19–21 | 23 | 4.5 | 15 |
| CXA260005E | 22–23 | 26 | 4.5 | 15 |
| CXA280005E | 24–26 | 28.5 | 4.5 | 16 |
| CXA320005E | 27–29 | 32 | 4.5 | 18 |
| CXA360005E | 30–32 | 36 | 4.5 | 18 |
Contralateral Leg Endoprosthesis | ||||
|---|---|---|---|---|
| Catalogue Number | Intended iliac vessel diameter (mm) | Iliac Endoprosthesis diameter (mm) | Contralateral Leg length (cm) | Recommended introducer sheath (Fr) |
| PLC121000 | 10–11 | 12 | 10 | 12 |
| PLC121200 | 10–11 | 12 | 12 | 12 |
| PLC121400 | 10–11 | 12 | 14 | 12 |
| PLC141000 | 12–13.5 | 14.5 | 10 | 12 |
| PLC141200 | 12–13.5 | 14.5 | 12 | 12 |
| PLC141400 | 12–13.5 | 14.5 | 14 | 12 |
| PLC161000* | 13.5–14.5 | 16 | 9.5 | 12 |
| PLC161200* | 13.5–14.5 | 16 | 11.5 | 12 |
| PLC161400* | 13.5–14.5 | 16 | 13.5 | 12 |
| PLC181000* | 14.5–16.5 | 18 | 9.5 | 12 |
| PLC181200* | 14.5–16.5 | 18 | 11.5 | 12 |
| PLC181400* | 14.5–16.5 | 18 | 13.5 | 12 |
| PLC201000* | 16.5–18.5 | 20 | 9.5 | 12 |
| PLC201200* | 16.5–18.5 | 20 | 11.5 | 12 |
| PLC201400* | 16.5–18.5 | 20 | 13.5 | 12 |
| PLC231000* | 18.5–21.5 | 23 | 10 | 14 |
| PLC231200* | 18.5–21.5 | 23 | 12 | 14 |
| PLC231400* | 18.5–21.5 | 23 | 14 | 14 |
| PLC271000* | 21.5–25 | 27 | 10 | 15 |
| PLC271200* | 21.5–25 | 27 | 12 | 15 |
| PLC271400* | 21.5–25 | 27 | 14 | 15 |
* PLEASE NOTE: 16, 18, 20, 23, 27 mm Contralateral Leg Endoprostheses can be used as Iliac Extenders.
Iliac Extender Endoprosthesis | ||||
|---|---|---|---|---|
| Catalogue Number | Intended iliac vessel diameter (mm) | Iliac Endoprosthesis diameter (mm) | Contralateral Leg length (cm) | Recommended introducer sheath (Fr) |
| PLL161007 | 8–9 | 10 | 7 | 12 |
| PLL161207 | 10–11 | 12 | 7 | 12 |
| PLL161407 | 12–13.5 | 14.5 | 7 | 12 |
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
INDICATIONS FOR USE IN EUROPE:
Trunk-Ipsilateral Leg Endoprosthesis and Contralateral Leg Endoprosthesis Components
The GORE® EXCLUDER® Conformable AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below:
- Adequate iliac / femoral access
- Infrarenal aortic neck treatment diameter range of 16–32 mm
- A minimum aortic neck length of 10 mm when proximal aortic neck angulation is ≤ 60°
- A minimum aortic neck length of 15 mm when proximal aortic neck angulation is ≤ 90°
- Iliac artery treatment diameter range of 8–25 mm and iliac distal vessel seal zone length of at least 10 mm
Aortic Extender Endoprosthesis and Iliac Extender Endoprosthesis Components
The Aortic and Iliac Extender Endoprostheses are intended to be used after deployment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis. These extensions are intended to be used when additional length and / or sealing for aneurysmal exclusion is desired.
CONTRAINDICATIONS: The GORE® EXCLUDER® Conformable AAA Endoprosthesis is contraindicated in:
- Patients with known sensitivities or allergies to the device materials.
- Patients with a systemic infection who may be at increased risk of endovascular graft infection.