Expandable Stent Graft Treats Peripheral Artery Disease

A novel balloon expandable stent graft aids treatment of de novo or restenotic lesions found in the iliac arteries, including lesions at the bifurcation.

The Viabahn VBX balloon expandable endoprosthesis consists of a 316L surgical grade stainless steel balloon expandable stent and a fluoropolymer graft with a proprietary heparin surface of porcine origin. The VBX is available in diameters ranging from 5 to 11 millimeters and lengths of 15, 19, 29, 39, 59, and 79 millimeters, as well as two shaft lengths, thus covering a wide variety of treatment needs up to 110 mm. In addition, it does not require pre-dilation, thus reducing the number of balloons required, contributing to procedural cost savings.

The VBX endoprosthesis is pre-mounted on a delivery system compatible with 0.035" guidewires, and is equipped with two radiopaque balloon markers embedded in the shaft to aid in correct placement. The delivery system can also be used for initial stent placement and post stent dilatation. The Viabahn VBX balloon expandable endoprosthesis is a product of Gore Medical Products, and has been approved by the U.S. Food and Drug Administration (FDA).

“The VBX Stent Graft combines radial strength with trackability and implanted conformability that results in successful outcomes for patients, providers, and physicians,” said Ray Swinney, peripheral interventional business leader at Gore. “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 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, MD, of Houston Methodist Hospital, who led the clinical study of the device. “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.”

PAD is a narrowing of the peripheral arteries due to atherosclerosis, and is most common in the arteries of the pelvis and legs. The most common symptoms of PAD are cramping, pain, or tiredness in the leg or hip muscles while walking or climbing stairs, which is temporarily relieved by rest. PAD sufferers have four to five times more risk of heart attack or stroke, and if left untreated, it can lead to gangrene and amputation.