News | EP Lab | March 05, 2020

FDA Clears Acutus Medical SuperMap EP Mapping System 

Technology enables super fast electrical mapping and re-mapping of the entire heart chamber in under 3 minutes

The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical SuperMap, an addition to its AcQMap 3-D imaging and mapping system used to guide electrophysiology (EP) catheter ablation procedures. Adding the SuperMap mode to the AcQMap system enables users to visualize any atrial rhythm in less than three minutes. Rapidly mapping and re-mapping the whole heart chamber facilitates a new procedural workflow in EP ablation, making it practical to execute an iterative "map, ablate, re-map" approach.

March 5, 2020 — The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical SuperMap, an addition to its AcQMap 3-D imaging and mapping system used to guide electrophysiology (EP) catheter ablation procedures. Adding the SuperMap mode to the AcQMap system enables users to visualize any atrial rhythm in less than three minutes. Rapidly mapping and re-mapping the whole heart chamber facilitates a new procedural workflow in EP ablation, making it practical to execute an iterative "map, ablate, re-map" approach to diagnosis and therapy.

SuperMap is a high-fidelity, high-resolution mapping algorithm for both stable and transient arrhythmias. SuperMap's user interface guides electrophysiologists to quickly create 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.  

With this 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 (SuperMap).

Initial European Experience With EP Hover Mapping

The AcQMap System with SuperMap received European CE marked clearance in October of 2019.

"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 Tom Wong, M.D. FRCP FHRSE, electrophysiologist, Royal Brompton and Harefield NHS Foundation Trust, London.

https://www.rbhh-specialistcare.co.uk/specialists/tom-wong

"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 Gian-Battista Chierchia, M.D., electrophysiologist, Vrije Universiteit Brussel, Brussels, Belgium.

First Clinical Cases U.S. Using EP Hover Mapping

"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, M.D., professor of medicine at UC San Diego School of Medicine and director of the cardiac electrophysiology program at UC San Diego Health.

"We recently completed an extraordinary case with the Acutus system and SuperMap. We captured three whole-chamber maps, targeted three ablation sites, and the patient left in sinus rhythm -- all in the span of one hour," said Arjun Gururaj, M.D., electrophysiologist, Nevada Heart and Vascular Center in Las Vegas. "These are notoriously complex atrial tachycardias that the EP community knows about. SuperMap can show potential sources and likely mechanisms in those complex cases in minutes as opposed to hours with conventional systems -- because we are seeing things that we couldn't see before.  Now we may be able to  do something about it in far less time with better acute results. It has amazing potential."

For more information: www.acutusmedical.com

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