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A case study using the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface*

Challenge

  • 65-year-old woman presented with severe peripheral arterial disease, claudication and rest pain of left lower extremity
  • Angiography revealed total occlusion of the left superficial femoral artery (SFA) 
Image
Severe peripheral arterial disease (PAD)"


Images courtesy of James Otto, M.D. Used with permission.

Procedure

  • Obtained percutaneous access into the right femoral artery with ultrasound guidance. Then performed an angiogram of the left lower extremity.
  • Crossed SFA chronic total occlusion (CTO) with 0.035” TERUMO® RADIOFOCUS® GLIDEWIRE® ADVANTAGE and 0.035” TERUMO® NAVICROSS® Support Catheter
  • Atherectomy completed with CARDIOVASCULAR SYSTEMS DIAMONDBACK 360® Peripheral Orbital Atherectomy System 2.0 Solid Crown
  • Followed by angioplasty with a 5 mm percutaneous transluminal angioplasty (PTA) balloon
  • Deployed two 6 mm x 15 cm VIABAHN® Devices in the SFA and post-dilated with 6 mm PTA balloon
Image
Severe peripheral arterial disease (PAD)


Images courtesy of James Otto, M.D. Used with permission.

Result 

  • Completion angiogram showed excellent flow of the left lower extremity. Immediately post-op, complete resolution of left sided severe claudication.
  • At follow-up office visit 2.5 weeks post-op, the patient presented with complete resolution of claudication and rest pain. Patient had palpable tibial pulses bilaterally
Image
Severe peripheral arterial disease (PAD)


Images courtesy of James Otto, M.D. Used with permission.

Case takeaways 

As demonstrated in this case, the VIABAHN® Device offers excellent patency in the treatment of long SFA total occlusions and should be considered first-line treatment for complex SFA disease
 

The VIABAHN® Device has demonstrated durability and long-term patency in treatment of complex SFA disease with

97% three-year secondary patency

(27 cm average lesion length, 93% CTOs)1

 

 

Related case study 


* As used by Gore, PROPATEN Bioactive Surface refers to Gore's proprietary CBAS® Heparin Surface.

  1.  Böhme T, Noory E, Brechtel K, et al. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: 36-month results of the Viabahn 25 cm trial. Journal of Endovascular Therapy. 2021;28(2) 222-228. https://journals.sagepub.com/doi/pdf/10.1177/1526602820965965


This content is for informational purposes only, is not advice or a guarantee of outcome. It is not a substitute for professional medical advice, diagnosis or treatment. Individual results and/or treatment may vary based upon the circumstances, the patient’s specific situation, and the healthcare provider’s medical judgment.

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: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is indicated for the treatment of:

  • de novo or restenotic lesions in the iliac arteries
  • de novo or restenotic lesions in the superficial femoral artery and proximal popliteal artery
  • in-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery
  • stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts and in the venous outflow of dialysis access circuits, including the central veins
  • popliteal artery aneurysms and isolated visceral artery aneurysms
  • traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) 

CONTRAINDICATIONS: 

  • Non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
  • Do not use the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
Product may not be available in all countries. Please check with your Gore representative for availability.