FDA Approves Abbott's RX Herculink Elite Renal Artery Stent System

August 10, 2011—Abbott Vascular (Santa Clara, CA) announced that it has received US Food and Drug Administration (FDA) approval for the RX Herculink Elite renal stent system for the treatment of renal artery stenosis in patients with uncontrolled hypertension. The RX Herculink Elite has been commercially available in Europe since 2007 for peripheral indications.

Abbott Vascular stated that the RX Herculink Elite is a cobalt chromium, rapid-exchange renal stent system. It is available in diameters ranging from 4 to 7 mm (including half sizes) and lengths of 12, 15, and 18 mm. The cobalt chromium alloy allows for thin stent struts, providing increased flexibility while maintaining strength to support the vessel and visibility during implantation.

According to the company, this approval is supported by the HERCULES study, which demonstrated that the RX Herculink Elite is safe and effective in patients with renal artery stenosis and uncontrolled hypertension. The study enrolled 202 patients at 37 study sites in the United States. It met its primary endpoint with a significantly low restenosis rate of 10.5% at 9 months posttreatment (P < .0001).

The investigators reported very low safety event rates, with 99% of patients experiencing no kidney-related safety complications within 30 days after treatment. A reduction in systolic blood pressure was seen in approximately 78% of patients at 9 months. The greatest reduction was seen in patients who had the highest blood pressure levels at the start of the study; 94% of patients with baseline systolic blood pressure ≤ 180 mm Hg experienced an average decrease of 48 mm Hg, the HERCULES investigators found.

“One striking result of the HERCULES study was the reduction in blood pressure we saw with RX Herculink Elite in patients with uncontrolled hypertension—those who are not adequately managed with multiple blood pressure medications,” commented HERCULES Study Director Michael R. Jaff, DO. “This result supports renal stenting as an important treatment option, as elevations in blood pressure can increase heart disease and stroke risk in patients with renal artery stenosis.”