Cardiotek receives FDA 510(k) clearance for software version 2.2

Schwarzer Cardiotek today announced that it was granted 510(k) clearance by the United States Food and Drug Administration for the software version 2.2 of its electrophysiogical measuring system EP-TRACER. The EP-TRACER is an electrophysiological measurement system, which was developed to display intracardiac ECG signals at the highest possible signal quality. New Features of software version 2.2 include the display of the compound motor action potential (CMAP) and venous pressure response during pacing of the phrenic nerve, a method typically applied during ablation procedures of atrial fibrillation. Other new features include immediate screenshots and export of relevant images to the final report, which can be automatically generated according to user specific templates and – if desired – may be stored on the hospital network. “The EP-TRACER’s ability to display the cryo-curve in real-time, together with the visualization of the response of phrenic nerve pacing greatly improves comfort and safety during my cryo-ablation procedures”, says Prof. Dr. Carlo de Asmundis at Universitair Ziekenhuis Brussel, Belgium. Frank-Peter Klein, President & CEO of Schwarzer Cardiotek comments “Atrial fibrillation is becoming an epidemic burden in our society. Giving electrophysiologists the opportunity to treat it most efficiently at the lowest possible risk is a motivation which has led to the improvements of EP-TRACER and its new software release.”

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