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Boston Scientific approvals

This article was originally published in The Gray Sheet

Executive Summary

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...

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