APN Health Receives FDA Clearance for Innovative Cardiac Mapping System

PLEASANTON, Calif., APN Health, LLC announced it received US Food and Drug Administration (FDA) clearance to market Navik 3D™, an advanced cardiac mapping system that reduces the cost and complexity of electrophysiology procedures. Navik 3D gives Electrophysiologist/Cardiologists real-time 3D catheter location in the heart from the 2D fluoroscopic images 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.

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

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.

"FDA clearance of Navik 3D represents a major milestone for APN Health’s team," says Jasbir Sra, MD, FHRS, CEO and Founder of APN Health, LLC. "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."

Source: APN Health, LLC