Electrophysiology tool developer APN Health said today it won FDA 510(k) clearance for its Navik 3D advanced cardiac mapping system.
The system from Pleasanton, Calif.-based APN Health is designed to give operating electrophysiologists or cardiologists real-time 3D catheter locations using 2D fluoroscopic images correlated with the electrical activation of the heart to create 3D maps.
“FDA clearance of Navik 3D represents a major milestone for APN Health’s team. We are proud that we’ve been able to develop a cost effective and simple technology that allows physicians throughout the world to more easily, accurately, and confidently complete their procedures. Looking forward, our proprietary digital image processing techniques and algorithms provide us with a remarkable platform from which to provide even greater functionality for electrophysiologists,” CEO Dr. Jasbir Sra said in a press release.
The Navik 3D produces maps that highlight locations with abnormal heart rhythms such as atrial fibrillation, the company said. APN Health claims it is the 1st system of its kind that does not require specialized equipment, and instead uses patient monitoring and fluoroscopic imaging already present in electrophysiology labs.
Clearance was supported by data demonstrating the system’s ability to accurately identify catheter locations in the heart and create 3D maps of the cardiac chamber of interest, the company said.
The system includes a workstation and iPad designed to display real-time 3D cardiac maps in a number of different formats.
