Hansen Medical IDE
This article was originally published in The Gray Sheet
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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Firm's "next generation" robotic coronary catheter system gains FDA market go-ahead, the firm announces Sept. 15. The device supports the new Artisan Extend control catheter, which "increases the reachability and navigation properties of the existing Artisan catheter by offering more than 20% improvement in both bend and reach," the company claims. Shipments will begin in the third quarter. In addition, Hansen's Lynx robotic irrigated ablation catheter, also supported by the Sensei X platform, will debut in Europe in the first half of 2010, pending CE mark approval, the company notes. Hansen's original Sensei robotic catheter system was cleared in 2007 for manipulation and control of electrophysiology mapping catheters (1"The Gray Sheet" May 14, 2007)
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