Building on the proven performance of the GORE® EXCLUDER® Device family, the conformable stent graft and innovative delivery system offer new levels of control when you need it most.

Continuing the pattern of performance

I am impressed with how well the device performed in the clinical study and appreciate the efforts of the investigators who contributed to this milestone.

– Robert Rhee, M.D., Chief of Vascular and Endovascular Surgery, Maimonides Medical Center, Brooklyn, New York , National Principal Investigator

* For these data points, a minimum of 66 patients were eligible for one year outcome analysis, meeting all follow-up requirements that included contrast enhanced CT’s. More than 66 patients were included in some data points, which can be confirmed in the Instructions for Use.

 One-year follow-up. Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms. NLM Identifier: NCT02489539. Published July 3, 2015. Updated June 16, 2020. Accessed November 17, 2020. https://clinicaltrials.gov/ct2/show/NCT02489539

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GORE® EXCLUDER® Conformable AAA Endoprosthesis
INDICATIONS FOR USE IN THE U.S.: The GORE® EXCLUDER® Conformable AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation and 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 15 mm; Proximal aortic neck angulation ≤ 60°; Iliac artery treatment diameter range of 8-25 mm and iliac distal vessel seal zone length of at least 10 mm. The GORE® EXCLUDER® Conformable Aortic Extender Endoprosthesis (Aortic Extender) is intended to be used after deployment of the GORE® EXCLUDER® Conformable Trunk-Ipsilateral Leg Component. The Aortic Extender is 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 to allergies to the device materials. Patients with systemic infection who may be at increased risk of endovascular graft infection. 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

 

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