Abbott has received the US Food and Drug Administration (FDA) approval for its RX Herculink Elite Renal Stent System to treat renal artery stenosis in patients with uncontrolled hypertension.
The cobalt chromium, rapid-exchange renal stent system is available in diameters ranging from 4 to 7 mm and lengths of 12, 15 and 18 mm.
The approval was based on Herculink Elite Cobalt Chromium Renal Stent trial (Hercules), a prospective study designed to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System.
The study, which enrolled 202 patients at 37 study sites in the US, met its primary endpoint, with a low restenosis (vessel re-narrowing) rate of 10.5% at nine months post-treatment (p<0.0001).
Abbott Vascular Medical Affairs chief medical officer and divisional vice president Charles Simonton said the results from Hercules, particularly the notable low restenosis rate and beneficial impact on blood pressure, support renal artery stenting as an important treatment option that can have a major impact on patient care.