Product Value—GORE® EXCLUDER® AAA Endoprosthesis

Consistently proven to deliver low rates of reintervention and ease-of-use for proven, durable value

Image of GORE EXCLUDER AAA Endoprosthesis deviceThe GORE® EXCLUDER® AAA Endoprosthesis is a device that allows for endovascular repair of an abdominal aortic aneurysm. Clinically proven with low reintervention rates and low renal complications, as demonstrated below:

Image showing the proven low re-intervention rates and low renal complications for GORE EXCLUDER AAA Endoprosthesis

Provides patient benefits

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  • 20+ years and more than 400,000 patients
  • Less invasive endovascular surgery may allow for faster recovery (versus open surgery)1

 

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GORE® EXCLUDER® AAA Endoprosthesis full product information

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INDICATIONS FOR USE: Trunk-Ipsilateral Leg Endoprosthesis and Contralateral Leg Endoprosthesis Components. The GORE® EXCLUDER® 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 19 – 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. 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® AAA Endoprosthesis. These extensions are intended to be used when additional length and/or sealing for aneurysmal exclusion is desired.

CONTRAINDICATIONS: The GORE® EXCLUDER® 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.

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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* GREAT. N=3,274. To calculate the overall event rates from procedure through end of study period, all subjects who could have had events, regardless of length of follow-up, were included.  For outcome data, GREAT only collects site reported serious adverse events.  Therefore, all reported endoleaks are defined as serious and require intervention.

† Inclusion for renal complication rate: Subjects with renal complication were identified with MedDRA code. Of those identified with MedDRA code as having a renal complication, only those who showed the SAE occurring within 75 days of the procedure AND were reported by the site/physician as being related to the deice or procedure were included in the renal complication rate.

‡ Based on U.S. clinical studies and post approval registries.

  1. Kothandan H, Haw Chieh GL, Khan SA, Karthekeyan RB, Sharad SS. Anesthetic considerations for endovascular abdominal aortic aneurysm repair. Annals of Cardiac Anaesthesia 2016;19(1):132-141. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4900395/

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