TriActiv approval
This article was originally published in The Gray Sheet
Executive Summary
Kensey Nash's 12-rep direct U.S. sales force will market the embolic protection system for saphenous vein graft (SVG) procedures following 510(k) clearance, announced March 24. TriActiv will compete with Boston Scientific's FilterWire and Medtronic's GuardWire in the estimated $100 mil.-$120 mil. marketfor SVG embolic protection. Kensey Nash is eyeing further indications and future-generation systems to expand the market (1"The Gray Sheet" March 21, 2005, p. 27)...
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Kensey Nash
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)...
Kensey Nash Predicts FDA Will Approve TriActiv In Next 30 Days
U.S. clearance of Kensey Nash's TriActiv embolic protection system will not be affected by the fact that FDA has not yet approved drug-eluting stents for treating saphenous vein grafts
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