The clinical trial will assess the safety and technical performance of the ECGenius System and benchmark electrogram signal quality compared to other commercially available systems
Medical technology firm CathVision has completed patient recruitment in the first US clinical trial of its low-noise electrophysiology (EP) recording technology, ECGenius System.
ECGenius System will be initially evaluated by the University of Vermont Medical Center as the firm prepares to launch the technology in the US.
The clinical trial will assess the safety and technical performance of the ECGenius System and benchmark electrogram signal quality compared to other commercially available systems.
CathVision CEO Mads Matthiesen said: “ECGenius delivers a modern approach built on improved visualisation and higher quality raw data that paves the way for more informed and accurate decision-making processes in the EP lab.
“This is necessary, foundational change and will become the basis for artificial intelligence-driven therapy support and machine learning software tools.”
ECGenius, which is yet to receive approval for commercial use in the US or Europe, is said to be an important evolution in the ECG signal acquisition quality, interpretation and therapy support.
The system features a 12-lead ECG, four blood pressure channels and 128 intracardiac channels and can be easily integrated into modern hospital environments.
Additionally, ECGenius System is compatible with existing catheters and 3D mapping systems.
It has been designed to guide and enhance ablation therapy by receiving low-noise, high-fidelity EP signals.
ECGenius System includes a low-noise console and computer software and provides a real-time artificial intelligence (AI) research platform to hospital partners.
Its special toolbox and algorithm catalogue will help interpret intelligent electrogram.
The company said it will partner with additional study sites to assess ECGenius and support the development of solutions that are based on AI and can be integrated into the system.