transparent man that illustrates where Gore Medical products are in the body

* Based on U.S. clinical studies and post-approval registries.
† Based on company-sponsored trials and registries shown on clinicaltrials.gov for currently available stent grafts.
‡ 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.
§ 99.2% of amputee patients had PAD

  1. Shaw SE, Preece R, Stenson KM, et al. Short stay EVAR is safe and cost effective. European Journal of Vascular & Endovascular Surgery 2019;57(3):368-373.
  2. Van Gool F, Houthoofd S, Mufty H, Bonne L, Fourneau I, Maleux G. Long-term outcome results after endovascular aortoiliac aneurysm repair with the bifurcated Excluder endoprosthesis. Journal of Vascular Surgery 2022;75(6):1882-1889.e2.
  3. Pratesi G, Piffaretti G, Verzini F, De Blasis G, Castelli P, Pratesi C. Ten-year outcome analysis of the Italian Excluder Registry with the Gore Excluder endograft for infrarenal abdominal aortic aneurysms. Journal of Vascular Surgery 2018;67(3):740-746.
  4. Poublon CG, Holewin S, van Sterkenburg SMM, Tielliu IFJ, ZeebregtsCJ, Reijnen MMP. Long-term outcome of the GORE EXCLUDER AAA Endoprosthesis for treatment of infrarenal aortic aneurysms. Journal of Vascular & Interventional Radiology 2017;28(5):637-644.e1.
  5. Atkins E, Milner R, Delaney CL; Global Registry for Endovascular Aortic Treatment (GREAT) Participants. Raised BMI is associated with fewer Type I endoleaks in patients treated with the Gore Excluder device: data from the Global Registry for Endovascular Aortic Treatment (GREAT). Journal of Cardiovascular Surgery 2023;64(5):513-520.
  6. Murphy TP. Medical outcomes studies in peripheral vascular disease. Journal of Vascular & Interventional Radiology 1998;9(6):879-889.
  7. Stern JR, Wong CK, Yerovinkina M, et al. A meta-analysis of long-term mortality and associated risk factors following longer extremity amputation. Annals of Vascular Surgery 2017;42:322-327.
  8. Hoffmann F, Claessen H, Morbach S, Waldeyer R, Glaeske G, Icks A. Impact of diabetes on costs before and after major lower extremity amputations in Germany. Journal of Diabetes & its Complications 2013;27(5):467-472.
  9. Iqbal K, Schumann E. Cost-consequence analysis of EPTFE vascular grafts with heparin end point covalent bond compared to standard EPTFE vascular grafts in below-knee surgical bypass for critical limb ischemia PAD patients in Germany. Presented at ISPOR Europe (International Society for Pharmacoeconomics and Outcomes); November 6-9, 2022; Vienna, Austria. Value in Health 2022;25(12)Supplement:S114. EE306. 
IFU Consult instructions

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 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 19–32 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® 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. 

 

INDICATIONS FOR USE IN EUROPE:  GORE® PROPATEN® Vascular Graft is indicated for patients who require replacement or bypass of peripheral vessels due to occlusive or aneurysmal diseases or trauma, or for patients who require arteriovenous hemodialysis access in the upper or lower extremities due to end-stage renal disease (ESRD). GORE® PROPATEN® Vascular Graft Configured for Pediatric Shunt is indicated for staged palliative repair of cyanotic congenital heart disease (CCHD).  

CONTRAINDICATIONS:

DO NOT use the GORE® PROPATEN® Vascular Graft in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II.  

DO NOT use any of the below configurations of GORE® PROPATEN® Vascular Graft for coronary artery bypass or cerebral reconstruction procedures:  

  • GORE® PROPATEN® Vascular Graft Integrated Rings  
  • GORE® PROPATEN® Vascular Graft Fixed Ring  
  • GORE® PROPATEN® Vascular Graft Removable Ring  
  • GORE® PROPATEN® Vascular Graft Removable Ring Axillobifemoral  

DO NOT use GORE® PROPATEN® Vascular Graft as a patch. If cut and used as a patch, GORE® PROPATEN® Vascular Graft may lack adequate transverse strength.  

FOR PATCHING APPLICATIONS: For cardiovascular procedures requiring patch materials, use the appropriate GORE® ACUSEAL Cardiovascular Patch.

Product may not be available in all countries. Please check with your Gore representative for availability. 
25PR2018-EN01