Boston Scientific enters U.S. carotid stent fray
This article was originally published in The Gray Sheet
Executive Summary
Firm gains FDA approval for its NexStent carotid stent and Monorail delivery system Nov. 3. The self-expanding, self-tapering nitinol stent, manufactured by EndoTex and distributed exclusively by Boston Scientific outside the U.S. since 2005, is indicated for use in patients with carotid artery disease at serious risk of surgery. The firm had previously anticipated approval in the second quarter of 2007. A second carotid stent from Boston Scientific, the Carotid WallStent Monorail, remains stalled in review due to hang-ups from a corporate warning letter the firm received last January (1"The Gray Sheet" Sept. 11, 2006, p. 6)...