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Kensey Nash

This article was originally published in The Gray Sheet

Executive Summary

Clinical trials for the TriActiv balloon protected flush extraction system commence in Europe and U.S., firm announces May 24. First U.S. patient receives the device May 30; the European trial began the previous week. U.S. trial is expected to involve up to 50 sites and 800 patients with enrollment slated for completion in late 2002, when the firm plans to submit a 510(k). A primary clinical endpoint is reduction in major adverse cardiac events. The TriActiv, a redesigned version of the Aegis Vortex, is engineered to protect against distal embolization and to extract occlusive debris during stent treatment of occluded saphenous vein grafts (1"The Gray Sheet" March 5, 2001, p. 14)
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