RX Herculink Elite® renal stent system: a review of its use for the treatment of renal artery stenosis

Abstract

William R Colyer JrDivision of Cardiovascular Medicine, University of Toledo Medical Center, Toledo, OH, USAAbstract: The management of renal artery stenosis (RAS) remains controversial. While some evidence suggests that treatment with stent placement is beneficial, randomized trials have failed to demonstrate a significant benefit. Ongoing clinical trials should help to better define the role for stenting of RAS while avoiding limitations seen with earlier trials. When it comes to stenting for RAS, several stents have been used; however, many stents which have been used previously and which are still being used are biliary stents that are used “off-label.” These stents have typically come onto the market through the 510(k) pathway. To date, a total of five stents have been approved by the United States Food and Drug Administration for use in the renal arteries. Of the five stents that have received approval, the Bridge™ Extra Support (Medtronic CardioVascular, Santa Rosa, CA) and the Palmaz® (Cordis Corporation, Bridgewater, NJ) stents are no longer available. Currently, the Express® SD (Boston Scientific, Natick, MA), Formula™ (Cook Medical, Bloomington, IN), and Herculink Elite® (Abbott Vascular, Santa Clara, CA) stents are Food and Drug Administration approved and available for use. The Herculink Elite is the most recently approved of the renal stents, having received approval in late 2011. The Herculink Elite stent is the only cobalt chromium stent approved for use in the renal arteries. Although trial data are limited and direct comparisons among renal stents is not possible, the Herculink Elite stent has demonstrated good performance. Additionally, the design of the Herculink Elite offers some advantages that may translate into improved outcomes.Keywords: renal artery stenosis, stenting, FDA approval