Acutus Medical secures FDA clearance, CE mark for SuperMap and announces first procedures in U.S. and initial experience in EU

Acutus Medical secures FDA clearance, CE mark for SuperMap and announces first procedures in U.S. and initial experience in EU

Press releases may be edited for formatting or style | February 20, 2020 Artificial Intelligence Cardiology
CARLSBAD, Calif., Feb. 18, 2020 /PRNewswire/ -- Acutus Medical today announced FDA clearance and CE Mark of SuperMap – a revolutionary addition to its AcQMap 3D Imaging and Mapping System. SuperMap is a high-fidelity, high-resolution mapping algorithm for both stable and transient arrhythmias. SuperMap's user interface effortlessly guides electrophysiologists to quickly create exquisitely detailed whole-chamber maps of the left or right atrium using its unique non-contact roving "hover-map" approach. This allows electrophysiologists to diagnose and treat arrhythmia patients rapidly, consistently and potentially more effectively. Adding the SuperMap mode to the AcQMap system enables users to visualize any atrial rhythm in under three minutes. Rapidly mapping and re-mapping the whole heart chamber facilitates a new procedural workflow in EP ablation -- by making it practical to execute an iterative "map, ablate, re-map" approach to diagnosis and therapy.

With this groundbreaking addition, Acutus Medical delivers the only EP imaging and mapping system to offer three mapping modalities: contact mapping, non-contact mapping and non-contact hover mapping -- known as SuperMap.

Initial Experience EU*

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"In less than three minutes, the AcQMap System can map the entire chamber to clearly identify re-entrant circuits, regions of slow conduction and focal origins. The Automatic Beat Grouping algorithm of SuperMap is helpful to map alternating or changing atrial tachycardias by categorizing and displaying multiple tachycardias occurring at the same time," said Dr. Tom Wong, Electrophysiologist, Royal Brompton & Harefield NHS Foundation Trust, London, England.

"Dynamic atrial substrate characterization is an emerging diagnostic strategy involving mapping of sinus and paced rhythms to identify clinically relevant areas of slow conduction, lines of block and critical zones of irregular activity. These areas may correlate with arrhythmia initiation or maintenance. SuperMap is the ideal tool for implementing this strategy. Within seconds, I can review the maps and identify zones of slow conduction," said Dr. Gian-Battista Chierchia, Electrophysiologist, Vrije Universiteit Brussel, Brussels, Belgium.

First Cases US

"It is critical to map repetitive rhythms in patients with irregular heartbeats. This approach is extremely helpful in identifying areas of low amplitude which may indicate scar. I am looking forward to integrating new technology into my workflow for the treatment of any arrhythmia," stated Gregory Feld, MD, Professor of Medicine at UC San Diego School of Medicine and director of the Cardiac Electrophysiology Program at UC San Diego Health.

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