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US FDA clears Hansen's visualisation device

This article was originally published in Clinica

Executive Summary

Hansen Medical's CoHesion 3D visualisation module has gained US FDA 510(k) clearance for use in complex electrophysiology (EP) mapping procedures. It is designed to help surgeons to "instinctively" navigate a catheter during the diagnostic phase of a complex cardiac arrhythmia procedure, the Mountain View, California firm said. The CoHesion module has a software interface between Hansen's Sensei robotic catheter system and the EnSite system – 3D mapping software developed by St Jude Medical. EnSite's cardiac chamber model with anatomic labelling is imported into the Sensei system's main navigation window, allowing physicians to see the location of the catheter within the heart in three dimensions. The CoHesion module was launched in the EU earlier this year.

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