GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System
GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System is not authorized for use in Canada.
New degree of control
Offering the only on-label EVAR solution in highly angulated aortic necks up to 90° and neck length of 10 mm or more, the conformable stent graft and innovative delivery system builds on the proven performance of the GORE® EXCLUDER® Device family.
Adapts to challenging anatomy
- Nesting stent rows help achieve optimal aortic wall apposition.
- Individual stent rings adapt closely to the anatomy to maximize the seal.
Improves ease of repositioning
- Reconstrainable proximal anchors for refined positioning.
- Initial trunk deployment at ~70% diameter.
Aids orthogonal placement
- Optional angulation control at 2 stages.
- Helps optimize seal in highly angulated necks.
Active infrarenal fixation
- Anchors engineered to provide migration resistance.
- Reduced risk of renal impairment.
Continuing the pattern of performance
Patients with neck angles between 60° and 90° outcomes: 1-year follow-up*
97.9%
Technical success
98.9%
Freedom from device-related serious adverse events
ZERO REPORTED
Type III endoleaks, Migrations, Ruptures, Stent fractures
4
Type I endoleaks†
1
Conversion to open repair‡
1
Device occlusion§
Change in AAA diameter||
26 (34.7%)
≥ 5 mm decrease
48 (64.0%)
NO CHANGE
1 (1.3%)
≥ 5 mm increase
Dedicated clinical device expertise to facilitate complex cases
- Pre-case planning and procedural consultation.
- Representatives support hundreds of aortic cases per year, so you’re backed by deep expertise.
The next generation in aortic accessories
Related to this product
* For these data points, 91 patients were eligible for 1-year outcome analysis.
† Core Lab identified endoleaks. 3 patients with Type l endoleaks were resolved at 1-year follow-up, 1 patient died of unrelated causes before 1-year follow-up.
‡ Subject underwent open surgical repair without explant of the EXCLUDER® Conformable Device, was determined the event to be unrelated to the device or the procedure.
§ Same patient that had to convert to open repair.
ll Change in AAA diameter as identified from baseline imaging taken closest to post-operative day 30 and no later than post-operative day 90.
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 THE U.S.: 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 and a minimum aortic neck length of 10 mm; Proximal aortic neck angulation ≤ 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 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. All components of the GORE® EXCLUDER® Conformable Endoprosthesis contain expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), nitinol (nickel-titanium alloy) and gold. Patients with systemic infection who may be at increased risk of endovascular graft infection.