Navik 3D is designed for use in an EP laboratory where interventional procedures utilize fluoroscopic images and body surface ECGs, as well as recordings obtained from catheters placed inside the heart. All EP laboratories have these capabilities. The purpose of the device is to make available the 3D location information of mapping and ablation catheters (and other useful information) by using only a single plane fluoroscope and the electrograms (ECG and intracardiac recordings), thus making this technology far more available to the EP physicians throughout the world.
Navik 3D automatically detects the mapping and ablation catheter in the 2D fluoroscopic images. The user can observe the incoming fluoro stream live in the upper left portion of the Navik 3D interface.
When Take Point is selected, Navik 3D's image processing algorithms determine the precise 3D location of the mapping catheter from the fluoroscopic images.
The Point List includes all points taken for a given map, including Activation, Ablation, Location and Scar Points. The user can change this default to filter the list to show only one category of points at a time. The Point List is located in the lower left of the Navik 3D interface.
This section of the Navik 3D screen displays the 3D model of the cardiac chamber of interest and allows the user to rotate the model to any desired point of view. It is located in the top center.
Navik 3D automatically detects the cardiac cycle length and also marks the reference and mapping channel recordings to determine the local activation time or voltage at the current location of the mapping and ablation catheter. Annotation results are displayed in the lower right portion of the Navik 3D interface.
Navik 3D users can continuously monitor the cardiac rhythm by observing the Real-Time ECG window in the bottom left corner of the Navik 3D interface.
Navik 3D™ is intended for catheter-based atrial and ventricular mapping using compatible catheters, and acquired data from compatible fluoroscopy systems and patient recording and monitoring systems. Navik 3D is intended to provide 3D location of these catheters from acquired 2D fluoroscopic images. The device allows real-time display of cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps and cardiac voltage maps.
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