Topera, a US-based medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its third generation 3D mapping system.
According to the company, its 3D mapping system has the capability of processing information in seconds and provides near-instantaneous intra-procedural mapping and re-mapping capabilities.
The new system features a new color-imaging module which helps in identifying ‘Rotors’, an electrophysiologic phenomenon previously shown to sustain atrial fibrillation.
In addition to 510(k) approval for Topera’s 3D mapping system, the company also obtained regulatory clearances and launched its proprietary FIRMap panoramic contact-mapping basket catheter in the US and Europe in late 2013.
The FDA has approved FIRMap for use in all cardiac chambers to assist in the diagnosis of complex arrhythmias.
Topera CEO Edward Kerslake noted the company pioneered the field of advanced electrophysiologic mapping with the introduction of its 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," Kerslake added.
Topera will exhibit the workstation at the 19th International AF Symposium in Orlando, 9 January to 11 January 2014.