Bard vascular stent for iliac procedures nets FDA approval

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C. R. Bard has received approval from the FDA to market the E*Luminexx vascular stent, a self-expanding nitinol stent to be marketed by the Bard Peripheral Vascular Division of Tempe, Ariz.

The E*Luminexx vascular stent is intended to treat patients with common or external iliac artery occlusive disease, for which more than 140,000 patients are candidates for iliac stent procedures in the United States, according to the Murray Hill, N.J.-based Bard.

The company said its prospective, multi-center, non-randomized, clinical study of 134 patients measuring the E*Luminexx vascular stent against objective performance criteria demonstrated a nine-month primary patency of 94.03 percent and a site reported anatomic success rate ( <30 percent final residual stenosis) of 98.72 percent.