Renal Vascular

Formula™ 414 RX Renal Balloon-Expandable Stent

Cook Medical

Indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous transluminal renal angioplasty (PTRA) of a de novo or restenotic lesion (= 18 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0-7.0 mm. Suboptimal PTRA is defined as = 50% residual stenosis, = 20 mm Hg systolic or = 10 mm Hg mean translesional pressure gradient or flow-limiting dissection.