02.24.14
The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to Topera Inc.'s latest generation of its 3D Mapping System.
The new system processes information in seconds, providing near-instantaneous intra-procedural mapping and re-mapping capabilities, according to the Palo Alto, Calif.-based firm. In addition, the system incorporates a new color-imaging module to help identify ‘rotors,’ an electrophysiologic phenomenon previously shown to sustain atrial fibrillation. These functionalities enable clinicians to better diagnose complex arrhythmias.
“Atrial fibrillation is an incredibly challenging arrhythmia to treat and the complexity of this disorder has defied interpretation and visualization by traditional EP mapping approaches,” said Eric Prystowsky, M.D., director of Clinical Electrophysiology at St. Vincent Hospital in Indianapolis, Ind. “Topera’s technology is the first to demonstrate an ability to reflect the complex mechanism(s) of this arrhythmia and provide a way to visualize the tissue sources sustaining it.”
In addition to FDA 510(k) clearance for its 3D Mapping System,Topera also obtained regulatory clearances and launched its proprietary FIRMap panoramic contact-mapping basket catheter in the U.S. and Europe. FIRMap is a contact-mapping basket catheter cleared by the FDA for use in all cardiac chambers to help doctors diagnose complex arrhythmias.
Topera is a venture-backed medical device company that has developed a 3-D analysis and mapping system to identify the electrical source of complex cardiac arrhythmias. The Topera 3D Mapping System, which consists of the RhythmView Workstation and the FIRMap diagnostic catheter, is 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.
The new system processes information in seconds, providing near-instantaneous intra-procedural mapping and re-mapping capabilities, according to the Palo Alto, Calif.-based firm. In addition, the system incorporates a new color-imaging module to help identify ‘rotors,’ an electrophysiologic phenomenon previously shown to sustain atrial fibrillation. These functionalities enable clinicians to better diagnose complex arrhythmias.
“Atrial fibrillation is an incredibly challenging arrhythmia to treat and the complexity of this disorder has defied interpretation and visualization by traditional EP mapping approaches,” said Eric Prystowsky, M.D., director of Clinical Electrophysiology at St. Vincent Hospital in Indianapolis, Ind. “Topera’s technology is the first to demonstrate an ability to reflect the complex mechanism(s) of this arrhythmia and provide a way to visualize the tissue sources sustaining it.”
In addition to FDA 510(k) clearance for its 3D Mapping System,Topera also obtained regulatory clearances and launched its proprietary FIRMap panoramic contact-mapping basket catheter in the U.S. and Europe. FIRMap is a contact-mapping basket catheter cleared by the FDA for use in all cardiac chambers to help doctors diagnose complex arrhythmias.
Topera is a venture-backed medical device company that has developed a 3-D analysis and mapping system to identify the electrical source of complex cardiac arrhythmias. The Topera 3D Mapping System, which consists of the RhythmView Workstation and the FIRMap diagnostic catheter, is 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.