Boston Scientific Carotid Stent 2004 Launch Will Court Vascular Surgeons
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific will complete enrollment of its 775-patient U.S. pivotal carotid stent trial by year-end
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Carotid stent trial
Boston Scientific completes enrollment of single-arm BEACH trial evaluating FilterWire EZ embolic protection system and carotid Wallstent Monorail endoprosthesis for treatment of high-risk carotid endarterectomy patients (1"The Gray Sheet" Feb. 18, 2002, p. 14). According to firm, the prospective, non-randomized clinical study has registered 747 patients at 47 U.S. sites...
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Boston Scientific completes enrollment of single-arm BEACH trial evaluating FilterWire EZ embolic protection system and carotid Wallstent Monorail endoprosthesis for treatment of high-risk carotid endarterectomy patients (1"The Gray Sheet" Feb. 18, 2002, p. 14). According to firm, the prospective, non-randomized clinical study has registered 747 patients at 47 U.S. sites...
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FilterWire EX embolic protection device for saphenous vein graft treatment will launch the week of June 16. Cleared via 510(k), FilterWire is supported by the firm's FIRE equivalence study comparing the device with Medtronic/PercuSurge's GuardWire Plus. The trial demonstrated a 9.9% major adverse cardiac event rate for FilterWire versus 11.6% for GuardWire. FilterWire, obtained via the 2001 acquisition of Embolic Protection, Inc., also is being evaluated in the 40-center BEACH trial with Boston Scientific's Wallstent for a carotid stenting indication (1"The Gray Sheet" Feb. 18, 2003, p. 14). On June 10, the company also announced FDA and European CE mark approval of its Cutting Balloon Ultra, intended to access lesions unreachable by the previous-generation device...