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)...
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Boston Scientific acquires NexStent carotid stent maker EndoTex International Jan. 4 following PMA approval of the device Oct. 27 (1"The Gray Sheet" Nov. 13, 2006, In Brief). While terms of the deal were not disclosed, Boston Scientific told the Securities and Exchange Commission it expected to pay about $100 million for the company, mostly in stock, on top of $40 million it had already invested, plus future milestone payments. NexStent has been distributed exclusively by Boston Scientific outside the United States since 2005. The device is intended for use with Boston Scientific's FilterWire EZ embolic protection system for carotid revascularization of patients at high risk for adverse events from carotid endarterectomy (2"The Gray Sheet" Dec. 18, 2006, In Brief)...
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