Distal protection device submission
This article was originally published in The Gray Sheet
Executive Summary
Kensey Nash projects a July 510(k) submission for its TriActiv saphenous vein graft surgery distal protection device. The firm expects clearance this year, but no longer anticipates launching the system by the Transcatheter Cardiovascular Therapeutics meeting in Washington, D.C. in September, as Kensey Nash previously stated in January. Former estimates were based on the assumption that a 510(k) based on the 894-patient PRIDE trial would be filed in April (1"The Gray Sheet" Jan. 26, 2004, p. 5)...
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