Hansen nets FDA clearance for cardiac EP 3D visualization module

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Hansen Medical, a developer of robotic technology for accurate 3D control of catheter movement during cardiac procedures, has received the FDA 510(k) clearance to market the CoHesion 3D visualization module for use in electrophysiology (EP) mapping procedures.

The integrated EP solution offers a software interface between the Hansen’s Sensei robotic catheter system and the EnSite system advanced mapping software from St. Jude Medical, according to the Mountain View, Calif.-based Hansen.

Hansen’s platform solution offers physicians the ability to navigate a catheter during the diagnostic phase of a cardiac arrhythmia procedure. The new CoHesion module imports the EnSite System’s 3D cardiac chamber model with anatomic labeling into the Sensei system’s main navigation window, allowing physicians to see the location of Hansen’s Artisan Control Catheters within the heart in 3D, the company.

Earlier this year, Hansen said that the CoHesion module was released in the European Union and there are currently eight European Sensei systems configured with the new module.