ABBOTT PARK, Ill.—The U.S. Food and Drug Administration (FDA) has approved Abbott’s 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. 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.
"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, DO, 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. "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."
RX Herculink Elite uses cobalt chromium technology. 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, according to Abbott.
