FDA OK's Balloon Expandable Stent Graft for the Iliac Artery
Gore has announced that the Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) has received approval from the Food and Drug Administration (FDA). The stent is indicated for the treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation.
The approval was based on a clinical study of 134 patients; 32% with Trans-Atlantic Inter-Society (TASC) II type C or D lesions, 18% who required contralateral access to the lesion, and 42% involved kissing stents at the aortic bifurcation. Results were positive for the stenting procedure and for efficacy over 9 months.
All target lesions in the trial were reduced to less than, or equal to, 30% of the original stenosis. “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 Jean Bismuth, MD, about the trial.
The VBX Stent Graft is available in a range of diameters from 5 to 11 millimeters and lengths of 15, 19, 29, 39, 59, and 79 millimeters.For more information visit Goremedical.com.