INDICATIONS FOR USE: The GORE® CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs). CONTRAINDICATIONS: The GORE® CARDIOFORM Septal Occluder is contraindicated for use in patients: Unable to take anti-platelet or anticoagulant medications such as aspirin, heparin, or warfarin; with anatomy where the GORE® CARDIOFORM Septal Occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins; with active endocarditis, or other infections producing bacteremia, or patients with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement; with known intracardiac thrombi. Refer to Instructions for Use at goremedical.com for a complete description of all warnings, precautions and adverse events.℞ only

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 and patients with a systemic infection who may be at increased risk of endovascular graft infection. Refer to Instructions for Use at goremedical.com for a complete description of all warnings, precautions and adverse events.℞ only

INDICATIONS FOR USE: The GORE® TAG® Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta, including: Isolated lesions in patients who have appropriate anatomy, including: adequate iliac / femoral access, aortic inner diameter in the range of 16 – 42 mm, ≥ 20 mm non-aneurysmal aorta proximal and distal to the lesion; Type B dissections in patients who have appropriate anatomy, including: adequate iliac / femoral access, ≥ 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected, diameter at proximal extent of proximal landing zone in the range of 16 – 42 mm. CONTRAINDICATIONS: Patients with known sensitivities or allergies to the device materials; patients who have a condition that threatens to infect the graft. Refer to Instructions for Use at goremedical.com for a complete description of all warnings, precautions, and adverse events.℞ only

INTENDED USE / INDICATIONS: The GORE® VIABAHN® Endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm, in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm, and in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE® VIABAHN® Endoprosthesis is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts. Refer to Instructions for Use at goremedical.com for a complete description of all contraindications, warnings, precautions and adverse events.℞ only

  1. Bosiers M, Deloose K, Callaert J, et al. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve month results from a multicenter randomized trial. Journal of Endovascular Therapy 2015;22(1):1-10.
  2. Krankenberg H; on behalf of the FAIR Trial Investigators. DCB and ISR: Insights from the FAIR Study. Presented at the Leipzig Interventional Course (LINC); January 27-29, 2015; Leipzig, Germany.
  3. Dippel EJ; EXCITE ISR Investigators. EXCITE ISR: initial results. Presented at the Transcatheter Cardiovascular Therapeutics Twenty-Sixth Annual Symposium Transcatheter Cardiovascular Therapeutics (TCT); September 13-17, 2014; Washington, DC.
  4. Deloose K. RELINE - randomized clinical trial: Viabahn covered stents vs. PTA. Presented at The Leipzig Interventional Course (LINC) 2014; January 28–31, 2014; Leipzig, Germany.