Topera, a US-based medical device company, has announced the US Food and Drug Administration (FDA) 510(k) approval and commercial availability of its FIRMap catheter and RhythmView 3D mapping workstation.
For clinicians, the RhythmView 3D mapping workstation provides a dynamic representation of the electrical activity of the heart using electrograms that are captured with the FIRMap panoramic contact-mapping basket catheter.
The clinicians can then use this diagnostic information to tailor therapy for excellent patient outcomes.
Topera CEO Edward Kerslake noted this FDA clearance and the recently received international CE Marks for both FIRMap and RhythmView represent a series of significant milestones for the company.
"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.
"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," Kerslake added.
The Topera 3D mapping system includes the RhythmView workstation and the FIRMap diagnostic catheter.
This mapping system has been designed to improve patient outcomes by enabling electrophysiologists to view a dynamic representation of the electrical activity of the heart, supporting the diagnosis of and treatment planning for a variety of arrhythmias including atrial fibrillation, atrial flutter, atrial tachycardia, and ventricular tachycardia.