Kensey Nash TriActiv
This article was originally published in The Gray Sheet
Executive Summary
Firm predicts delay in distal protection system launch as it enters into another question-and-response tango with FDA. The firm replied to a previous round of inquiries last November. Kensey Nash plans to have 10 TriActiv sales reps on hand upon 510(k) clearance in "the near term." The device will compete with Boston Scientific's FilterWire and Medtronic's GuardWire in the $100 mil. SVG embolic protection market (1"The Gray Sheet" Jan. 24, 2005, p. 24)...