FDA Approves GORE VIABAHN VBX Balloon Expandable Endoprosthesis for Expanded Use in Complex Aortic Repair
W. L. Gore & Associates' medical business has received U.S. Food and Drug Administration (FDA) approval for an expanded indication of its GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent Graft). The device is now approved for use in fenestrated and branched endovascular aortic repair (FEVAR and BEVAR), marking the first on-label bridging stent graft for these complex procedures. Three-year clinical outcomes from the EMBRACE Registry supported the safety and effectiveness of the device.
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