FDA approves RX Herculink Elite renal stent system for treatment of renal artery disease


The RX Herculink Elite renal stent system has FDA approval for the treatment of renal artery stenosis in patients with uncontrolled hypertension. This approval is supported by the HERCULES (Herculink elite cobalt chromium renal stent trial to demonstrate efficacy and safety) study, which demonstrated that RX Herculink Elite is safe and effective in patients with renal artery stenosis and uncontrolled hypertension.

RX Herculink Elite is the first stent using cobalt chromium technology to gain a renal indication in the United States. The cobalt chromium alloy allows for thin stent struts, providing increased flexibility while maintaining strength to support the vessel and visibility during a stent implantation procedure for accurate placement.


“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,” said Michael R Jaff, medical director of the Vascular Center and VasCore, the Vascular Ultrasound Core Laboratory that participated in the HERCULES trial, both at the Massachusetts General Hospital in Boston, USA. “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.”


HERCULES met its primary endpoint, with a significantly low restenosis rate of 10.5% at nine months post-treatment (p 180 mmHg experienced an average decrease of 48 mmHg). The study enrolled 202 patients at 37 study sites in the USA.


“The strong 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,” said Charles A Simonton, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular.




About Herculink Elite


The RX Herculink Elite renal stent system is a cobalt chromium, rapid-exchange renal stent system. It is available in diameters ranging from 4.0 to 7.0 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.