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ASPIRE for TriActiv FX

This article was originally published in The Gray Sheet

Executive Summary

Kensey Nash completed enrollment for its 100-patient, 20-center ASPIRE prospective registry Nov. 7, two months ahead of schedule, the firm announced. The second-generation TriActiv FX embolic protection system for saphenous vein graft procedures received a CE mark March 7 (1"The Gray Sheet" March 21, 2005, p. 27). The firm expects to submit a 510(k) application to FDA within 90 days and could roll out the device in the first half of 2006. FDA recently approved an investigational device exemption for a feasibility study to test TriActiv FX in carotid stenting procedures (2"The Gray Sheet" Nov. 7, 2005, In Brief)...
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