W.L. Gore & Assoc. said today that it won FDA approval for its Viabahn VBX stent graft for treating iliac artery lesions, including those found at the aortic bifurcation.
Flagstaff, Ariz.-based Gore said the approval means the device is the only balloon-expandable stent graft indicated for the iliac artery.
“The VBX stent graft combines radial strength with trackability and implanted conformability that results in successful outcomes for patients, providers and physicians,” peripheral intervention leader Ray Swinney said in prepared remarks.
“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,” added Dr. Jean Bismuth of the Houston Methodist Hospital. “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 dislodgment 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.”
Gore said its 134-patient investigational device exemption study, VBX Flex, showed a 100% success rate in device delivery and target lesion coverage. The success rate for reducing target lesions to 30% or less of the original stenosis was also 100% and there was no change in median device length on deployment, the company said.
Primary patency was 96.9% at 9 months and 95.3% in patients with lesions that usually require open surgery. There were no incidents of device dislodgment, stent failure or serious adverse events, Gore said.