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Gore’s expandable stent graft gets FDA approval for use in iliac artery

MDBR Staff Writer Published 31 January 2017

W. L. Gore & Associates (Gore) has secured approval from the US Food & Drug Administration (FDA) for its Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) for use in iliac artery.

The expandable stent graft has been approved to treat de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation.

VBX stent graft is claimed to be the only balloon expandable stent graft with an indication for the iliac artery.

According to the company, clinical data from the Gore VBX FLEX IDE clinical study carried out for FDA approval showed maximum success rate in device delivery and coverage of target lesions in all study subjects.

In addition, the trial demonstrated 100% success rate in reducing the target lesion to less than or equal to 30% of the original stenosis.

Through using small diameter and ePTFE stent graft technology, the company developed VBX stent graft from Viabahn endoprosthesis.

VBX Stent Graft is available in various diameters from 5mm to 11mm, as well as lengths of 15mm, 19mm, 29mm, 39mm, 59mm, and 79mm to cover different treatments.

Gore peripheral interventional business leader Ray Swinney said: “The VBX Stent Graft combines radial strength with trackability and implanted conformability that results in successful outcomes for patients, providers and physicians.”

Gore offers a portfolio of peripheral vascular solutions, which can be used to treat a range of challenging peripheral disease presentations.


Image: Gore has secured FDA approval for first expandable stent graft for use in iliac artery. Photo: courtesy of Business Wire.