Gore's balloon stent graft earns FDA nod to treat PAD in iliac artery

Previous procedures involved the off-label use of balloon stent grafts that had not been approved by the FDA to treat peripheral artery disease in the iliac artery. Image: W.L. Gore

The FDA approved W.L. Gore’s balloon expandable stent graft for use in the iliac artery, making it the first and only device of its kind approved to treat peripheral artery disease in this part of the body.

Peripheral artery disease affects as many as 9 million people in the U.S., according to the American Heart Association. It is characterized by narrowed blood vessels that limit blood flow to the limbs and commonly causes pain in the legs. Previous balloon expandable stent graft procedures in the iliac artery involved off-label use of devices that had not been FDA-approved for this artery, a Gore spokeswoman said.

The Viabahn VBX Balloon Expandable Endoprosthesis is approved for the treatment of restenotic lesions in the iliac artery, including the point where the artery splits into two vessels, according to a statement. It comes in diameters ranging between 5 and 11 millimeters and a variety of lengths between 15 and 79 millimeters.


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“Overall, there were multiple clinical benefits observed, including no median change in the device length upon deployment and a 100 percent technical success rate with no occurrences of stent dislodgement or significant residual stenosis,” said Dr. Jean Bismuth, a vascular surgeon at Houston Methodist, in the statement. “The study device performed well in disadvantaged lesions, including occlusions, which speaks to its trackability, radial strength, conformability, and stent retention.”

The device doesn’t need the artery to be predilated, so the procedure needs fewer balloons. It is also available in longer lengths, so multiple stents need not be used for longer lesions. Both factors can reduce the procedure’s cost, according to the statement.

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