Kensey Nash
This article was originally published in The Gray Sheet
Executive Summary
FDA approves an investigational device exemption for a feasibility study of the firm's new version of the TriActiv embolic protection system for carotid stenting procedures, Kensey announces Nov. 3. The study is scheduled to begin this month. The Exton, Penn. company has already commenced a similar study in Europe in pursuit of a CE mark, which it hopes to obtain in 2006. The TriActiv system was 510(k)-cleared in March for embolic protection during saphenous vein graft procedures (1"The Gray Sheet" March 28, 2005, In Brief)...