Topera, Inc., a medical device company that has developed a suite of products to assist in the identification of 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 latest generation of its 3D Mapping System. The workstation will be exhibited at the 19 th International AF Symposium in Orlando, January 9-11, 2014.
“Topera pioneered the field of advanced electrophysiologic mapping with the introduction of our 3D Mapping System in 2011. We remain committed to building upon this platform to further aid electrophysiologists (EP’s) in diagnosing complex arrhythmias and allowing them to tailor therapies to deliver improved clinical outcomes for their patients,” said Edward Kerslake, Chief Executive Officer of Topera, Inc.
The new system processes information in seconds, providing 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 electrophysiologic phenomenon previously shown to sustain atrial fibrillation. These functionalities enable EP’s 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, MD, Director, Clinical Electrophysiology at St. Vincent Hospital in Indianapolis, Indiana. “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 U.S. 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.