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.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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.”

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData
"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.

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
Awarded for Innovation in Remote Hearing Diagnostics , hearX’s Self Test Kit (STK) delivers clinically validated audiometry via smart devices, enabling remote, scalable hearing assessments in homes, clinics and retail. Learn how hearX is redefining hearing care delivery and reducing costs for providers globally.

Discover the Impact