FDA approves renal artery disease stent

The FDA has approved Abbott’s stent system for the treatment of renal artery disease in patients with high blood pressure.

RX Herculink Elite is the first stent using cobalt chromium technology to gain a renal indication in the US.

Cobalt chromium allows for thin stent struts, which provides flexibility while maintaining strength to support the vessel and improves visibility during stent implantations enabling more accurate placement.

Michael R. Jaff, Medical Director of the Vascular Center and VasCore, at the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston, said: “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”.

The approval was based on Abbott’s HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety) study.

The study involved 202 patients with renal artery stenosis at 37 sites in the US, and demonstrated that the stent is safe and effective, with a significantly low restenosis (vessel re-narrowing) rate of 10.5% at nine months post-treatment.

HERCULES is a prospective study designed to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in patients with atherosclerotic renal artery stenosis with uncontrolled hypertension.