APN Health granted FDA clearance for Navid 3D cardiac mapping system


APN Health has been granted marketing clearance from the US Food and Drug Administration for the Navid 3D cardiac mapping system.

The system produces real-time 3D catheter location information from 2D fluoroscopic images of the heart, and correlates them with the electrical activation of the heart to create 3D maps of cardiac chamber of interest in abnormal heart rhythms such as atrial fibrillation. According to a company release, the system should reduce the cost and complexity of electrophysiology procedures.

To assist in the procedure workflow, the system includes a workstation and iPad. It displays real-time 3D cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps, and cardiac voltage maps.

Navik 3D is the first cardiac mapping system that does not require specialised equipment, according to APN Health. Instead, it uses the patient monitoring and fluoroscopic imaging systems already present in electrophysiology labs. The Navik 3D clearance was supported by data which demonstrated Navik 3D’s ability to accurately identify catheter locations in the heart and create 3D maps of the cardiac chamber of interest.