Kensey Nash Predicts FDA Will Approve TriActiv In Next 30 Days
This article was originally published in The Gray Sheet
Executive Summary
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
You may also be interested in...
ASPIRE for TriActiv FX
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)...
ASPIRE for TriActiv FX
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)...
TriActiv approval
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)...