Large Diameter VIABAHN Endovascular Stents Approved in US

July 22nd, 2009 Editors Vascular Surgery

W. L. Gore & Associates has received FDA approval for the large size VIABAHN endoprosthesis for use in iliac arteries. The stents feature a heparinized surface for a localized anti-coagulation effect.

The next generation of the large diameter product enables streamlined deployment on the same 0.035” guidewire and TIP to HUB direction as the 5 – 8 mm sizes. Additional modifications to the large diameter GORE VIABAHN Endoprosthesis include radial device expansion, a contoured proximal edge and a lower profile that is now available for most sizes.
The GORE VIABAHN Endoprosthesis family of devices is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The product’s flexibility enables it to traverse tortuous areas and to conform to the complex anatomy of the artery.

Press release: Gore Receives FDA Approval for Next Generation of Large Diameter GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface…
Flashbacks: Smoother GORE VIABAHN Endoprosthesis Gets Approved in US; Gore VIABAHN Endroprosthesis Stent: Now Approved

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Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

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