Topera gets FDA 510(k) approval for 3D mapping system

7 January 2014 (Last Updated January 7th, 2014 06:30)

US-based medical device company Topera has announced that the US Food and Drug Administration (FDA) has granted 510(k) approval for the company's third-generation 3D mapping system.

US-based medical device company Topera has announced that the US Food and Drug Administration (FDA) has granted 510(k) approval for the company's third-generation 3D mapping system.

Processing information in seconds, the 3D mapping system provides near-instantaneous intra-procedural mapping and re-mapping capabilities.

The system features a new colour-imaging module that will help in the identification of 'Rotors', an electrophysiologic phenomenon previously shown to sustain atrial fibrillation.

"We remain committed to building upon this platform to further aid EPs in diagnosing complex arrhythmias and allowing them to tailor therapies to deliver improved clinical outcomes for their patients."

Topera CEO Edward Kerslake said: "We remain committed to building upon this platform to further aid electrophysiologists (EPs) in diagnosing complex arrhythmias and allowing them to tailor therapies to deliver improved clinical outcomes for their patients."

Topera will exhibit the workstation at the 19th International AF Symposium in Orlando, from 9-11 January.

The company has developed the 3D analysis and mapping system that will assist electrophysiologists in identifying the electrical source of complex cardiac arrhythmias.

The Topera 3D mapping system features RhythmView Workstation and the FIRMap diagnostic catheter.

According to Topera, the 3D mapping system improves patient outcomes by enabling electrophysiologists to view a dynamic representation of the electrical activity of the heart, and helps support the diagnosis of and treatment planning for a variety of arrhythmias including atrial fibrillation, atrial flutter, atrial tachycardia, and ventricular tachycardia.

In late-2013, the company also obtained regulatory approvals for its FIRMap panoramic contact-mapping basket catheter in the US and Europe and has launched the device in those countries.

Topera claims that 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.