Aurora Health Care Systems today touted the FDA Clearance of APN Health‘s Navik 3D Cardiac mapping system, originally developed by Aurora Health cardiac electrophysiologist Dr. Jasbir Sra at Aurora St. Luke’s Medical Center and the Aurora Research Institute.
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.
“Aurora Health Care and the Aurora Research Institute are proud to support the work of Dr. Sra and his talented team in the development of this leading-edge technology that will ultimately better treat patients with heart irregularities. Dr. Sra is a pioneer in his understanding of heart arrhythmias and we were thrilled to see the FDA clearance of Navik 3D,” Aurora Research Institute prez Randall Lambrecht said in prepared remarks.
Last month, APN Health announced it won FDA 510(k) clearance for its Navik 3D advanced cardiac mapping system. 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.