FDA Clears RX Herculink Elite Renal Stent System
August 2, 2011 – The U.S. Food and Drug Administration said it recently cleared Abbott Vascular’s RX Herculink Elite Renal Stent System.
The balloon-expandable, cobalt chromium, laser-cut stent is used to re-open narrowed regions of the renal arteries. The device comes in 12, 15 and 18 mm lengths and in diameters from 4 to 7 mm.
This device is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty of a de novo or restenotic atherosclerotic lesion located within 10 mm of the renal ostium. Suboptimal angioplasty is defined as more than 50 percent residual stenosis, more than 20 mmHg peak systolic or more than 10 mmHg mean translesional pressure gradient, flow-limiting dissection, or TIMI (thrombolysis In myocardial infarction) flow of less than 3.
In the HERCULES clinical study of 202 patients, the rate of restenosis of the artery at nine months was less in this study than the rate of restenosis reported in previous studies of renal artery stenting. Results also showed that kidney function and high blood pressure had not significantly worsened at nine months. Abbott will follow all of these patients for a total of three years to assess the long-term safety and effectiveness of the device.
The Herculink Elite has been commercially available in the United States as a biliary stent since March 6, 2006. In addition, the same device is sold commercially as a peripheral stent system in more than 80 countries outside the United States.
For more information: www.accessdata.fda.gov/cdrh_docs/pdf11/p110001a.pdf