Gore secures FDA approval for VBX stent graft use in iliac artery

30 January 2017 (Last Updated January 30th, 2017 18:30)

WL Gore & Associates has secured the US Food & Drug Administration (FDA) approval for its Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) for use in the iliac artery.

Gore secures FDA approval for VBX stent graft use in iliac artery

WL Gore & Associates has secured the US Food & Drug Administration (FDA) approval for its Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) for use in the iliac artery.

The stent graft can be used for the treatment of de novo or restenotic lesions in the iliac arteries, as well as lesions at the aortic bifurcation.

Developed using the small diameter, ePTFE stent graft technology from the Gore Viabahn Endoprosthesis, the new graft is claimed to combine radial strength with trackability and implanted conformability.

Houston Methodist Hospital Cardiovascular Surgery assistant professor Jean Bismuth said: "The VBX Stent Graft demonstrated notable immediate and nine-month safety and efficacy in treating patients with iliac occlusive disease which can be attributed to the exceptional device design.

“Overall, there were multiple clinical benefits observed, including no median change in the device length upon deployment and a 100% technical success rate with no occurrences of stent dislodgement or significant residual stenosis.

"The study device performed well in disadvantaged lesions, including occlusions, which speaks to its trackability, radial strength, conformability, and stent retention.”

"There were multiple clinical benefits observed, including no median change in the device length upon deployment and a 100% technical success rate with no occurrences of stent dislodgement or significant residual stenosis."

The clinical study conducted in 134 patients indicated that the graft is resilient during stenting procedures as well as over time.

The study did not find any device dislodgement, integrity failures, or related serious adverse events through the primary endpoint follow up.

Available in diametres from 5 to 11mm and lengths of 15, 19, 29, 39, 59, and 79 mm, the VBX stent graft does not require pre-dilation, minimising the number of balloons, while the availability of longer lengths decreases the necessity for use of multiple stents.


Image: Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent Graft). Photo: courtesy of WL Gore & Associates.