January 9, 2014 — Topera Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for the latest generation of its 3D Mapping System. The workstation will be exhibited Jan. 9-11 at the Boston AF Symposium 2014 in Orlando, Fla.
The Topera 3D Mapping System consists of the RhythmView Workstation and FIRMap diagnostic catheter.
The system provides 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 electrophysiological phenomenon previously shown to sustain atrial fibrillation (AF). These functionalities enable EPs to more efficiently 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, St. Vincent Hospital, Indianapolis. “Topera’s technology is the first to demonstrate an ability to reflect faithfully the complex mechanism(s) of this arrhythmia and provide a reliable way to visualize the tissue sources sustaining it.”
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 United States 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.
For more information: www.toperamedical.com, afsymposium.com