Stent graft gets FDA approval for iliac arteries

6th February 2017

Enaie Azambuja

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Gore won FDA approval for its VIABAHN VBX endoprosthesis to be used in the iliac arteries, making it the only balloon expandable stent graft having such an indication. It can be used on new or restenotic lesions within the iliac, including at the aortic bifurcation. Previously, vascular surgeons were only able to do such procedures off-label, utilising devices really developed for other applications.

The VBX was based on the original GORE VIABAHN endoprosthesis and utilises expanded polytetrafluoroethylene, or ePTFE, as the external material. The device is available in diameters from five to 11 millimeters, and lengths from 15 to 79 millimeters, allowing treatment of quite varied patients.

Some clinical data on the VIABAHN VBX within the iliacs, according to Gore:

Of the patients in the Gore VBX FLEX IDE clinical study (n=134), 32% presented with TASC II type C or D lesions, 18% required contralateral access to the lesion, and 42% involved kissing stents at the aortic bifurcation.

Clinical data from the Gore VBX FLEX IDE clinical study conducted for FDA approval reflected that the design components of the VBX Stent Graft were resilient both during stenting procedures and over time:

100% success rate in device delivery and coverage of target lesions in all study subjects;
100% success rate in reducing the target lesion to less than or equal to 30% of the original stenosis;
Zero change in median length of the device upon deployment; and
96.9% primary patency at nine-months, including a 95.3% primary patency rate in those patients with TASC II C or D type lesions.