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# FDA Approves Gore Balloon Expandable Endoprosthesis
- URL: https://www.fdaweb.com/fda-approves-gore-balloon-expandable-endoprosthesis/
- Published: 2017-01-30T12:00:00.000Z
- Updated: 2026-09-14T22:03:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137858

FDA has approved a W. L. Gore PMA for the Gore Viabahn VBX Balloon Expandable Endoprosthesis for treating *de novo* or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation. The device’s approval was based on a study that “demonstrated notable immediate and nine-month safety and efficacy in treating patients with iliac occlusive disease,” the company says. “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.”