Topera Medical (Palo Alto, CA) recently won FDA 510(k) clearance along with CE Mark approval for the FIRMap catheter, used to diagnose arrhythmias traditionally too complex for conventional mapping catheters. Used with Topera’s RhythmView 3D Electrophysiologic Mapping System workstation, the tip of the FIRMap catheter has a spherical wire basket with 64 integrated, evenly placed electrodes over the 8 splines that make up the basket. The basket is expandable, allowing it to capture all the contours of the heart chambers and create a panoramic map of electrical heart activity. Radiopaque markers on each spline help clinicians identify and position the basket under fluoroscopy.

The FIRMap detects the electric potential on the endocardial layer and the signals are then sent to the RhythmView 3D workstation for an almost real-time 3D reconstruction of the heart and its dynamic electrophysiological activity. The map is used to help diagnose cardiac arrhythmias, including atrial flutter, atrial tachycardia, ventricular tachycardia, and atrial fibrillation (AF). Although the workstation is optimized for the FIRMap, it maintains the flexibility to take electrograms from other multi-polar mapping catheters for the 3D electrical construction. It already has 510(k) approval and has been successfully used in almost 400 cases.

video
http://www.youtube.com/watch?v=MqX17C9Vwj4

source:Topera Medical