The RX Herculink Elite Renal Stent System by Abbott Vascular was given FDA premarket approval on July 20, 2011. The stent and its delivery system are approved for patients with atherosclerotic disease of the renal arteries who have had sub-optimal balloon angioplasty of a de novo or re-stenosed lesion. Approval has been restricted to particular lesion sizes, location, and vessel diameter. Sale and distribution are further limited to specific training sites or experienced practitioners.
The device works by delivering a cobalt chromium alloy stent pre-mounted on a balloon tip catheter via percutaneous (femoral) access of the vascular bed. The stent is then advanced over a guidewire positioned across the lesion and deployed from the delivery catheter by inflation of the pre-mounted balloon.
A recent prospective, non-randomized, multi-center, single-arm study (HERCULES trial) showed that systolic blood pressure was significantly reduced from a mean 162 mm Hg to 145 mm Hg at nine months (p<0.0001) in the 202 treated patients (mean age 72.1 years old, 62.4% female) after use of the RX Herculink Elite Renal Stent. All patients had a baseline blood pressure of greater than 140/90 mm Hg, were already on two antihypertensive medications, and failed prior balloon renal angioplasty. The restenosis rate at 9 months was 10.5%, acute procedure success rate was 99.2%, and freedom from major adverse events and repeat intervention was 94.8%.
The study, sponsored by Abbott Vascular, was recently presented at the Society for Cardiovascular Angiography and Interventions May 2011 Scientific Sessions.