Topera Medical landed 510(k) clearance from the FDA for the latest incarnation of its 3D Mapping System, featuring the RhythmView workstation and FIRMap diagnostic catheter.
The imaging system uses electrical signals, captured by a multipolar electrophysiology catheter, and creates a 3D image that can more accurately map cardiac arrhythmias.
A 2012 study of the 3D Mapping System found it had a 100% success rate in locating "rotors", signals in the heart that have been associated with atrial fibrillation. Researchers further reported that the mapping system allowed them to deliver more precisely targeted ablation therapy that resulted in a doubled success rate in treating atrial fibrillation.
The next-generation 3D Mapping System is able to process information faster and features color-imaging that helps better identify rotors, Topera said.
“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 in diagnosing complex arrhythmias and allowing them to tailor therapies to deliver improved clinical outcomes for their patients,” CEO Edward Kerslake said in prepared remarks.
The Palo Alto, Calif.-based medical device company in November won CE Mark approval in the European Union and 510(k) clearance from the FDA for the FIRMap catheter for use in mapping cardiac arrhythmias.