Abbott renal stenting trial
This article was originally published in The Gray Sheet
Executive Summary
Abbott enrolls first patient Sept. 25 in a U.S. trial for its RX Herculink Elite renal stent system. The 50-site HERCULINK single-arm study is expected to enroll 202 patients with renal artery stenosis who have not responded to drug treatment for hypertension by early 2009. Primary follow-up of patients implanted with the cobalt chromium stent will be at nine months, with additional analyses out to three years. CMS is in the process of reconsidering its national coverage policy for renal stenting, in part due to a perceived lack of evidence as to its efficacy (1"The Gray Sheet" July 23, 2007, p. 18)