An EVAR portfolio you can count on
When your patients are counting on you, you can count on us.
Every device in the portfolio is meticulously designed, made from durable materials and exhaustively tested, to ensure best-in-class performance.
GORE EXCLUDER
The most-studied EVAR device,* designed to provide an optimal infrarenal seal and reliable results.
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The only EVAR device with angulation control, offering controlled conformability when you need it most.
The only off-the-shelf, FDA-approved iliac branch device, and the recommended treatment to sustain quality of life.
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You’ve got all these tools available to you that you can use to cover the majority of your endovascular repairs for AAA.
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AAA Endoprosthesis
Conformable AAA Endoprosthesis
Iliac Branch Endoprosthesis
Europe
00800 6334 4673
United States
800 437 8181
928 779 2771
Flagstaff, AZ 86004
Asia Pacific
+65.67332882
Australia/New Zealand
1800 680 424
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. Products listed may not be available in all markets. GORE, Together, improving life, ACTIVE CONTROL, C3, EXCLUDER, MEDICAL MASTERY and designs are trademarks of W. L. Gore & Associates. © 2022 W. L. Gore & Associates, Inc. 22430038-EN AUGUST 2022
goremedical.com
W. L. Gore & Associates, Inc.
Chaikof EL, Dalman RL, Eskandari MK, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. Journal of Vascular Surgery 2018;67(1):2-77.e2. Moll FL, Powell JT, Fraedrich G, et al. European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical practice guidelines of the European Society for Vascular Surgery. European Journal of Vascular & Endovascular Surgery 2011;41(Supplement 1):S1-S58. Schneider DB. One-year U.S. results of GORE® EXCLUDER® Iliac Branched Endograft: Advantages and limitations. Presented at the 42nd Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (VEITHsymposium); November 17-21, 2015; New York, NY.
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References
* Based on company-sponsored trials and registries shown on clinicaltrials.gov for currently available stent grafts.
Device family
GORE EXCLUDER AAA Endoprosthesis
GORE EXCLUDER Conformable AAA Endoprosthesis
GORE EXCLUDER Iliac Branch Endoprosthesis
Performance you can count on
Collaboration you can count on
you can count on
Collaboration
Performance
– Vascular Surgeon
Durability you can count on
Proven performance. Proven outcomes.
Design and materials you can count on
Click a feature for details
Helps mitigate known risks associated with suprarenal fixation Anchors for active fixation are engineered to provide migration resistance 0.1% Migration*
Active infrarenal fixation
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• • •
• •
Engineered to provide security against endoleaks 0.9% Type la endoleaks*
Sealing cuff
•
Low permeability with abrasion-resistant properties
Proprietary ePTFE film layers
0.2% Type III endoleaks*
Sutureless stent-to-graft attachment
Enhances flexibility and long-term patency 0.7% Limb occlusion*
Advanced sinusoidal limb stent design
Outcomes you can count on
freedom from device-related reintervention migration type I endoleak
patients through FIVE years of follow-up*
3,274
94.7%
0.1%
1.6%
0.2%
0.7%
0.4%
The GORE EXCLUDER AAA Endoprosthesis allows for confident endovascular repair of abdominal aortic aneurysms.
Zettervall SL, Soden PA, Deery SE, et al. Comparison of renal complications between endografts with suprarenal and infrarenal fixation. European Journal of Vascular & Endovascular Surgery 2017;54(1):5-11. Saratzis A, Bath MF, Harrison S, et al. Long-term renal function after endovascular aneurysm repair. Clinical Journal of the American Society of Nephrology 2015;10(11):1930-1936.
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* Results from the real-world patient population enrolled in the Global Registry for Endovascular Aortic Treatment (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. † 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 device or procedure were included in the renal complication rate.
type III endoleak limb occlusion renal complications
A treatment range
Infrarenal aortic neck treatment diameter range of Minimum aortic neck length of Proximal aortic neck angulation Iliac artery treatment diameter range of Iliac distal vessel seal zone length of at least
19–32 mm 15 mm ≤ 60° 8–25 mm 10 mm
†
ContRol you can count on
The only EVAR device with angulation control
Innovation you can count on
Helps mitigate known risks associated with suprarenal fixation Anchors for active fixation are engineered to provide migration resistance ZERO Migration*
Engineered to provide security against endoleaks ZERO Type la endoleaks*
Individual stent rows help achieve aortic wall apposition in challenging anatomy
Conformable stent design
ZERO Type III endoleaks*
Enhances flexibility and long-term patency ZERO Limb occlusion*
The GORE EXCLUDER Conformable AAA Endoprosthesis with ACTIVE CONTROL System was designed to provide controlled conformability for each patient’s unique anatomy, allowing you to maximize seal.
* One-year follow-up from short neck sub-study. W. L. Gore & Associates. Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms. NLM Identifier: NCT02489539. Published July 3, 2015. Updated May 2, 2022. Accessed June 14, 2022. https://clinicaltrials.gov/ct2/show/NCT02489539 † 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.
Short neck sub-study outcomes. One-year follow-up.*
,†
Technical success Patency Freedom from device-related
Freedom from aneurysm enlargement
100%
Type I and III endoleaks Migrations Conversions to open repair Ruptures Stent fractures Limb occlusions
ZERO
98.6%
serious adverse events
16–32 mm 15 mm ≤ 60° 8–25 mm 10 mm
(an expanded treatment range for small aortic necks)
the solution physicians trust and patients count on
The only FDA-approved, off-the-shelf iliac branch solution
Advances you can count on
Branch components designed for use in the iliacs
All-in-One System
ZERO Type lII endoleaks*
Enhances flexibility and long-term patency 100% external iliac artery patency* 95.1% internal iliac artery patency*
Advanced sinusoidal stent design
Designed exclusively for use in the iliac arteries, the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) is the recommended treatment to sustain quality of life.
Chaikof EL, Dalman RL, Eskandari MK, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. Journal of Vascular Surgery 2018;67(1):2-77.e2. Moll FL, Powell JT, Fraedrich G, et al. European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical practice guidelines of the European Society for Vascular Surgery. European Journal of Vascular & Endovascular Surgery 2011;41(Supplement 1):S1-S58.
* U.S. IDE Clinical Trial. Sixty-three subjects with device implanted in initial cohort. Thirty-six patients have completed five-year follow-up. † Core Lab reported assessment for patency, endoleak, migration and CIAA enlargement (> 5 mm). Denominator is number of subjects evaluated for primary effectiveness endpoint result with an evaluable result. ‡ On the side treated with the IBE.
FIVE year data from the U.S. IDE clinical trial*
External iliac artery
Buttock claudication New onset erectile dysfunction Type I/III endoleaks Migrations
Freedom from IBE-related reintervention
95.2%
patency
Internal iliac artery
95.1%
Freedom from CIAA enlargement
98.3%
‡
Minimum common iliac diameter of at the proximal implantation site of the IBE External iliac artery treatment diameter range of and seal zone length of Internal iliac artery treatment diameter range of and seal zone length of
17 mm
at least 10 mm
6.5-25 mm
6.5-13.5 mm
Data you can count on
A proven legacy
PERFORMANCE you can count on
patients treated worldwide
25 years
450,000+
EVAR device family
Most studied*
of aortic device experience
The results speak for themselves
Explore the data
65-year-old male diagnosed with an infrarenal aortic aneurysm in 1999. Use of GORE EXCLUDER AAA Endoprosthesis. One of the first implants performed in Europe after the commercialization of the device.
Patient: Treatment:
20-year
follow-up
12
-month
48
With the GORE EXCLUDER Device family, you get a commitment that goes far beyond products.
A non-commissioned sales force — Our focus is on outcomes. Committed to supporting physicians in choosing the right product for each patient. If one of our products is not the right choice, we will say so.
Unbiased support
Deep expertise
Resources for physician education
A forward-looking legacy
Aortic representatives support hundreds of cases per year. Extensive experience and a deep reservoir of product knowledge. Pre-case planning and procedural consultation.
Gore MEDICAL MASTERY Courses — Clinical knowledge through peer-to-peer collaboration. Gore Medical Fellows Program — One-stop access to people, training and registration for key events. On-demand case planning resources, videos and other educational materials.
Multiple clinical and investigational trials in process supporting a robust aortic pipeline. Continually advancing aortic treatment capabilities with innovations in device design, deployment and materials.
