Abbott nabs FDA approval for renal stent
Abbott has received FDA approval for its RX Herculink Elite renal stent system for the treatment of renal artery stenosis in patients with uncontrolled hypertension. Over time, narrowed kidney arteries can lead to kidney failure and increased risk of heart disease, stroke and peripheral artery disease.
The RX Herculink Elite is the first stent using cobalt chromium alloy technology to gain a renal indication in the U.S. It is available in diameters ranging from 4 to 7 mm (including half sizes) and lengths of 12, 15 and 18 mm. RX Herculink Elite has been commercially available in Europe since 2007 for peripheral indications.
This approval is supported by the prospective HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety) study, which assessed the safety and efficacy of the RX Herculink Elite in patients with renal artery stenosis and uncontrolled hypertension. The study enrolled 202 patients at 37 study sites in the U.S.
The RX Herculink Elite is the first stent using cobalt chromium alloy technology to gain a renal indication in the U.S. It is available in diameters ranging from 4 to 7 mm (including half sizes) and lengths of 12, 15 and 18 mm. RX Herculink Elite has been commercially available in Europe since 2007 for peripheral indications.
This approval is supported by the prospective HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety) study, which assessed the safety and efficacy of the RX Herculink Elite in patients with renal artery stenosis and uncontrolled hypertension. The study enrolled 202 patients at 37 study sites in the U.S.