US FDA approves first balloon expandable stent graft to treat iliac arteries

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Gore Viabahn VBX

Gore has announced that the Gore Viabahn VBX balloon expandable endoprosthesis has received US FDA approval for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation.

This marks the availability of the only balloon expandable stent graft with an indication for the iliac artery.

“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,” said Jean Bismuth. He continued: “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.”

FLEX clinical study

Of the patients in the Gore VBX FLEX investigational device exemption 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 study conducted for US 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 patients
  • 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.

Further, there were no reported incidences of device dislodgement, failures in stent integrity, or device-related serious adverse events through the primary endpoint follow up, meaning no additional costs incurred for either endovascular or surgical stent removal. The VBX stent graft does not require predilation, which reduces the number of balloons required, and the longer lengths available reduce the need to use multiple stents for extensive lesions, both of which also contribute to procedural cost savings.

The VBX stent graft was developed utilising the small diameter, ePTFE stent graft technology from the Gore Viabahn Endoprosthesis. The VBX stent graft is available in a range of diameters from 5–11mm and lengths of 15, 19, 29, 39, 59, and 79mm to cover a wide variety of treatment needs.