Gore's Viabahn VBX Balloon-Expandable Stent Graft Approved to Treat Iliac Arteries

January 30, 2017—Gore & Associates announced that the US Food and Drug Administration (FDA) has approved the company's Viabahn VBX balloon-expandable endoprosthesis for treatment of de novo or restenotic lesions found in the iliac arteries, including lesions at the aortic bifurcation.

In Gore's announcement, Jean Bismuth, MD, commented, “The VBX stent graft demonstrated notable immediate and 9-month safety and efficacy in treating patients with iliac occlusive disease, which can be attributed to the exceptional device design."

Dr. Bismuth 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.”

The company advised that FDA approval of the VBX stent graft was supported by the Gore VBX FLEX investigational device exemption clinical study.

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.

Gore reported that the following clinical data from the study reflected that the VBX stent graft was resilient both during stenting procedures and over time:

• 100% success rate in device delivery and coverage of target lesions
• 100% success rate in reducing the target lesion to ≤ 30% of the original stenosis
• Zero change in median length of the device upon deployment
• 96.9% primary patency at 9 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; therefore, no additional costs were incurred for either endovascular or surgical stent removal.

The company noted that 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 utilizing the small-diameter, expanded polytetrafluoroethylene stent graft technology from the Viabahn endoprosthesis. The VBX stent graft is available in diameters from 5 to 11 mm and lengths of 15, 19, 29, 39, 59, and 79 mm to cover a wide variety of treatment needs, advised Gore & Associates.