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FLAGSTAFF, Ariz.-( )- has announced that the (VBX Stent Graft) hasreceived U.S. Food & Drug Administration (FDA) approval for treatment of denovo or restenotic lesions found in iliac arteries, includinglesions at the aortic bifurcation. This marks the availability of theonly balloon expandable stent graft with an indication for the iliacartery.“The VBX Stent Graft demonstrated notable immediate and nine-monthsafety and efficacy in treating patients with iliac occlusive diseasewhich can be attributed to the exceptional device design,” said JeanBismuth, MD.

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Bismuth continued, “Overall, there were multipleclinical benefits observed, including no median change in the devicelength upon deployment and a 100 percent technical success rate with nooccurrences of stent dislodgement or significant residual stenosis. Thestudy device performed well in disadvantaged lesions, includingocclusions, which speaks to its trackability, radial strength,conformability, and stent retention.”Gore VBX FLEX IDE Clinical StudyOf the patients in the Gore VBX FLEX IDE clinical study (n=134), 32percent presented with TASC II type C or D lesions, 18 percent requiredcontralateral access to the lesion, and 42 percent involved kissingstents at the aortic bifurcation.

FLAGSTAFF, Ariz.-( )- has announced that the (VBX Stent Graft) hasreceived U.S. Food & Drug Administration (FDA) approval for treatment of denovo or restenotic lesions found in iliac arteries, includinglesions at the aortic bifurcation. This marks the availability of theonly balloon expandable stent graft with an indication for the iliacartery.“The VBX Stent Graft demonstrated notable immediate and nine-monthsafety and efficacy in treating patients with iliac occlusive diseasewhich can be attributed to the exceptional device design,” said JeanBismuth, MD. Bismuth continued, “Overall, there were multipleclinical benefits observed, including no median change in the devicelength upon deployment and a 100 percent technical success rate with nooccurrences of stent dislodgement or significant residual stenosis. Thestudy device performed well in disadvantaged lesions, includingocclusions, which speaks to its trackability, radial strength,conformability, and stent retention.”Gore VBX FLEX IDE Clinical StudyOf the patients in the Gore VBX FLEX IDE clinical study (n=134), 32percent presented with TASC II type C or D lesions, 18 percent requiredcontralateral access to the lesion, and 42 percent involved kissingstents at the aortic bifurcation.