Topera, Inc., a medical device company that has developed a novel mapping and targeting system for the identification of the sources that sustain complex cardiac arrhythmias, today announced that it has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for the FIRMap Catheter.
"This FDA clearance and the recently received International CE Marks for both FIRMap and RhythmView represent a series of significant milestones for Topera," said Edward Kerslake, Chief Executive Officer of Topera. "With this product now commercially available, we are able to offer our panoramic diagnostic catheter with our next generation 3D mapping system. We believe this will help us expand our leadership in identifying and defining the discrete sources that sustain complex arrhythmias."
Using electrograms captured with the FIRMap panoramic contact-mapping basket catheter, the RhythmView Workstation provides electrophysiologists with a dynamic representation of the electrical activity of the heart. Clinicians can then use this diagnostic information to tailor therapy for excellent patient outcomes. Topera's 3D Mapping System is the first diagnostic tool designed to identify the patient-specific, unique electrophysiologic source that sustains serious heart rhythm disorders.
"The results 30 independent electrophysiologists have obtained to date using the previously cleared RhythmView Workstation and existing diagnostic catheters in nearly 400 atrial fibrillation patients have been remarkable. We believe patient outcomes will only improve with the introduction of the FIRMap catheter, which has been specifically optimized for RhythmView," said Kerslake.