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Hansen Medical IDE

This article was originally published in The Gray Sheet

Executive Summary

Investigational device exemption study of Hansen Medical's Sensei X robotic catheter system and Artisan Control catheter for treatment of atrial fibrillation is approved by FDA, the Mountain View, Calif., company announces May 12. The ARTISAN AF pivotal trial is a prospective, randomized study of Sensei X for introducing and positioning Johnson & Johnson/Biosense Webster's Navistar Thermocool catheter in 300 patients with symptomatic, drug-refractory paroxysmal AF. Primary endpoints are absence of early onset of all major adverse events and freedom from AF through one year. Sensei X was first approved by FDA last fall (1"The Gray Sheet" Sept. 28, 2009)

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