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

Abstract

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 Cardio- Vascular, 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.

Initial experience with the cook formula balloon expandable stent in congenital heart disease

“…Thus, most pediatric cardiologists have looked at using stents initially designed for biliary or renal work. Such stents have nominal diameters of 5–10(12) mm and potentially can be dilated further . Ex vivo bench testing, in particular to look at shortening characteristics of these stents during over dilation has been pioneered by Ing and Stern .…”

Proper Patient Selection Yields Significant and Sustained Reduction in Systolic Blood Pressure Following Renal Artery Stenting in Patients With Uncontrolled Hypertension: Long‐Term Results From the HERCULES Trial

“…At 12 and 36 months, freedom from CD‐TLR was 94.7% and 91.8%, respectively, demonstrating the durability of the study stent system (Figure ). The study stent system is currently the only cobalt chromium stent approved in the United States for use in the renal arteries and the unique design characteristics may have contributed to long‐term durability compared with the stainless steel alternatives …”

“…Office BP and renal function measurements were performed following the procedure and at 1, 6,9,12,24, and 36 months using accepted and reproducible techniques for BP assessment. All patients underwent renal artery duplex ultrasonography following the procedure and at 1, 9, 24, and 36 months.…”

“…The study stent system is currently the only cobalt chromium stent approved in the United States for use in the renal arteries and the unique design characteristics may have contributed to long-term durability compared with the stainless steel alternatives. 24…”