First Balloon Expandable Stent Graft for Iliac Artery Gets FDA Approval

FDA approved the VBX Stent Graft to treat restenotic lesions in iliac arteries.

The US Food and Drug Administration (FDA) approved the Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent Graft/ W.L. Gore & Associates) to treat restenotic lesions that appear in iliac arteries including lesions at the aortic bifurcation.

This is the only balloon expandable stent graft available on the market with an indication for the iliac artery. Additionally, the VBX Stent Graft does not require pre-dilation, which decreases the number of required balloons and longer lengths — both helping save procedure costs.

According to researchers, “The VBX Stent Graft demonstrated notable immediate and nine-month safety and efficacy in treating patietns with iliac occlusive disease, which can be attributed to the exceptional device design.”

The clinical study included 134 individuals of whom 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.

The results specifically showed multiple clinical benefits with using VBX Stent Graft:

• 100% success rate in device delivery and coverage of target lesions in all study subjects

• 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

• 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

The team also noted that the device performed well in disadvantaged lesions, including occlusions speaking to trackability, radial strength, conformability, and stent retention.

The researchers did not report any incidences of device dislodgment, failures in stent integrity, or device-related serious adverse events through primary endpoint follow-up.