Clinical Data for GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System
5-year pivotal trial outcomes with the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL system
The long-term performance of the EXCLUDER® Conformable Device was evaluated in an investigational prospective, multicenter, non-randomized pivotal trial.1
Of the 45 patients with sac measurements available at 5 years, over 85% demonstrated decreased or stable aneurysmal sac size compared to baseline1
5-year sac dynamics1
Proven 5-year EVAR durability1
freedom from
stent graft migration
freedom from
types I and III endoleaks
Additional clinical outcomes through 5 years (N = 80)1
freedom from aneurysm-related mortality
freedom from aortic rupture
freedom from conversion to open repair
freedom from device-related reintervention
freedom from limb occlusion
ADAPTABILITY IS THE DIFFERENCE
Gore’s EXCLUDER® Conformable AAA stent graft and innovative delivery system are supported by long-term performance and safety data, allowing you to focus more fully on your patients.1
The 5-year results from the pivotal clinical trial of the EXCLUDER® Conformable AAA Device demonstrate:
- A durable EVAR device for the treatment of AAA with short infrarenal seal zones1
- Low rates of major complications, including infrequent reinterventions and AAA sac expansion, and no aneurysm-related mortality, conversion to open repair, type I and type III endoleaks or limb occlusion1
WE’RE YOUR AORTIC ALLY
Over 25 years of helping physicians make informed treatment decisions with confidence.
a. Gore Imaging Sciences measurement.
b. Core laboratory measurement.
c. Site measurements.
d. Not part of the device effectiveness endpoint composite. Aneurysm sac stability and decrease in this table is not cumulative but rather is reflective of the number of patients (percent) at the individual timepoint. Patients must have a postoperative baseline and post-baseline image to be evaluable.
- Suckow BD, Oderich GS, Almadani MW, et al. Five-year pivotal trial outcomes of the GORE® EXCLUDER® Conformable Endoprosthesis implanted in abdominal aortic aneurysms with short non-angulated infrarenal seal zones. Journal of Vascular Surgery 2025;793–801.
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
GORE® EXCLUDER® Conformable AAA Endoprosthesis
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.