W.L. Gore (Flagstaff, AZ) has received expanded indication from the FDA for the VIABAHN Endoprosthesis to be used for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access grafts. The VIABAHN Endoprosthesis has long been approved for iliac and superficial femoral artery use, but now with the latest approval physicians can use this flexible, low profile endoprosthesis in challenging venous anastomotic locations such as across the elbow and regions where flex angles are greater than 90 degrees.
The VIABAHN Endoprosthesis consists of a nitinol stent structure that supports an inner lining of expanded polytetrafluoroethylene (ePTFE). The nitinol stent has a kink resistant design with no reported fractures in the REVISE Clinical Study while crossing complex anatomical locations such as the elbow. The inside surface of the ePTFE includes the addition of proprietary heparin-bonded technology called CARMEDA BioActive Heparin Surface to provide long term thromboresistance. The bioactive site in CARMEDA interacts with blood, while the end-point covalent bonding allows for heparin to be attached to the endoprosthesis’ surface. The self expanding stent graft comes pre-loaded on a delivery catheter.
The VIABAHN Endoprosthesis was successfully used in the REVISE Clinical Study to re-establish flow to occluded grafts and to increase patients’ time till the next intervention. In the same clinical study the VIABAHN Endoprosthesis showed superior target lesion primary patency compared to percutaneous transluminal angioplasty.
Product page: GORE VIABAHN® Endoprosthesis…