Abbott gets FDA OK for renal stent system

Abbott Vascular has received the FDA's blessing for the RX Herculink Elite renal stent system for the treatment of renal artery stenosis in patients with uncontrolled hypertension. It is the first stent using cobalt chromium technology to gain a renal indication in the U.S., according to a company statement.

Renal artery stenosis is the narrowing of one or both arteries that carry blood to the kidneys and is typically caused by atherosclerosis. Hypertension that is persistent, severe and difficult to control with medication can result. Over time, patients can develop kidney failure and are at increased risk for heart disease, stroke and peripheral artery disease.

The approval was supported by the HERCULES study, which demonstrated that RX Herculink Elite is safe and effective in this patient population. The study, which enrolled 202 patients in the U.S., met its primary endpoint, with a significantly low vessel re-narrowing rate of 10.5% at 9 months post-treatment. In addition, 99% of patients experienced no kidney-related safety complications within 30 days after treatment, according to the company. A reduction in systolic blood pressure was seen in approximately 78% of patients at 9 months, with the greatest reduction seen in patients who had the highest blood pressure levels at the start of the study.

Abbott has launched 5 new products in the U.S. and Europe to treat diseases of the periphery over the last 12 months. RX Herculink Elite adds to Abbott's portfolio of products to advance renal therapy, including balloon dilatation catheters and peripheral guide wires.

- see the Abbott release