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First balloon-expandable stent graft for use in iliac artery approved by FDA

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W.L. Gore and Associates announced the FDA approval of the first balloon-expandable stent graft for use in treatment of de novo or restenotic lesions in the iliac artery.

The stent graft (Gore Viabahn VBX Balloon Expandable Endoprosthesis) is the only balloon-expandable stent graft in the United States with an indication for the iliac artery, according to a press release from Gore.

Approval was based on results from the Gore VBX FLEX Investigational Device Exemption clinical study of 134 patients. According to the release, 32% of these patients presented with TransAtlantic Inter-Society Consensus II type C/D lesions, 18% required contralateral access to lesions and 42% needed kissing stents at aortic bifurcation.

According to the release, the stent graft was linked to a 100% success rate in device delivery and coverage of target lesions in all patients, as well as a 100% success rate in reducing the target lesion to ≤ 30% of original stenosis.

Additionally, there was no change in median length of the device upon deployment and a 96.9% primary patency rate at 9 months, including 95.3% for patients with TASC II C or D type lesions.

Researchers also reported no incidence of device dislodgement, stent integrity failure, or serious adverse events related to the device.

By requiring no predilation, the stent grafts reduce the number of balloons required and the need for multiple stents for extensive lesions, lowering procedural costs, the company stated in the release.

"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,” Jean Bismuth, MD, from Houston Methodist Hospital, said in the release. “The study device performed well in disadvantaged lesions, including occlusions, which speaks to its trackability, radial strength, conformability, and stent retention."

Disclosure: Bismuth reports no relevant financial disclosures.