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Boston Scientific Extends EndoTex Purchase Option; NexStent Evaluated

This article was originally published in The Gray Sheet

Executive Summary

EndoTex Interventional Systems is planning an early 2004 launch of its self-expanding NexStent carotid stent outside the U.S., using Boston Scientific as exclusive distributor under an extended agreement between the firms

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NexStent launches in Europe

Boston Scientific will distribute EndoTex' carotid stent for use with its Monorail delivery system in Europe, according to April 13 announcements from the firms. EndoTex plans to submit a PMA covering the use of NexStent in conjunction with Boston Scientific's FilterWire embolic protection device this summer, with approval expected in the first quarter of 2006. Boston Scientific has agreed to acquire EndoTex upon the completion of certain regulatory milestones (1"The Gray Sheet" May 26, 2003, p. 26)...

NexStent launches in Europe

Boston Scientific will distribute EndoTex' carotid stent for use with its Monorail delivery system in Europe, according to April 13 announcements from the firms. EndoTex plans to submit a PMA covering the use of NexStent in conjunction with Boston Scientific's FilterWire embolic protection device this summer, with approval expected in the first quarter of 2006. Boston Scientific has agreed to acquire EndoTex upon the completion of certain regulatory milestones (1"The Gray Sheet" May 26, 2003, p. 26)...

Carotid endarterectomy surgery

Preliminary feedback from a trial of EndoTex's NextStent carotid stent with Boston Scientific's FilterWire EX embolic protection device is "promising," according to Boston Scientific Peripheral Interventions Business President Matthew Jenusaitis. CABERNET recently completed enrollment of 450 patients ineligible for carotid endarterectomy surgery at 15 U.S. centers, the firms announced March 25. Boston Scientific will be the exclusive distributor for NextStent and has the option to buy EndoTex under the terms of a May 2003 agreement extension (1"The Gray Sheet" May 26, 2003, p. 26)...

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