Cardiac arrhythmias can be notoriously difficult to diagnose, often requiring invasive electrophysiological mapping on where ectopic impulses originate. Topera Medical, a company specializing in mapping the electrical signals of the heart, has been granted FDA approval to bring to market its 3rd generation 3D Mapping System.
The system consists of the RhythmView Workstation and FIRMap catheter that opens up into a wire ball with sensing electrodes along its surface. The workstation processes the signals coming in from the catheter and displays the electrophysiology data in near real-time on the screen.
From the announcement:
The new system processes information in seconds, providing near-instantaneous intra-procedural mapping and re-mapping capabilities. In addition, the system incorporates a new color-imaging module to aid identification of ‘Rotors,’ an electrophysiologic phenomenon previously shown to sustain atrial fibrillation. These functionalities enable EP’s to more efficiently diagnose complex arrhythmias.
In addition to FDA 510(k) clearance for Topera’s 3D Mapping System, the Company also obtained regulatory clearances and launched its proprietary FIRMap™ panoramic contact-mapping basket catheter in the U.S. and Europe in late 2013. FIRMap is the first and only contact-mapping basket catheter cleared by the FDA for use in all cardiac chambers to assist in the diagnosis of complex arrhythmias.