FDA Clears Software Updates for Atrial Arrhythmias Mapping System

The technology will be implemented into Acutus Medical’s AcQMap 3D imaging and mapping systems.

The US Food and Drug Administration (FDA) has cleared new software upgrades called AcQMap 8 aimed at highlighting regions of interest during the mapping and ablation of complex atrial arrhythmias.

The clearance and CE Mark allows Acutus Medical to move forward with new mapping algorithms, including AcQTrack and the SlowZone Locator for the AcQMap 3D imaging and mapping systems.

The Technology

The new software also includes a series of procedural workflow enhancements, as well as seamless integration of Acutus’ therapeutic ablation technologies where currently available.

The system allows for real-time mapping of individual beats with new mapping algorithms that automatically identify and analyze the presence of focal, partial-rotational, and irregular conduction patterns commonly associated with atrial fibrillation.

The SlowZone Locator algorithm identifies consistent areas of slow conduction over the entire atrium, allowing physicians to create 1 or more maps in the atria.

The Study

The technology has been tested in various clinical trials, and the UNCOVER AF study found that when 3-4 of the abnormal conduction patterns were targeted for ablation, and patients were 9 times more likely to be in sinus rhythm after 1 year.

“We’re seeing more and more clearly that the triggers and drivers for some of the most complex atrial arrhythmias lie beyond the reach of traditional pulmonary vein isolation treatment strategies,” said Tim Betts, MD, Oxford University Hospitals NHS Foundation Trust, in a statement. “AcQMap’s multiple algorithms, in combination with its non-contact full chamber mapping capabilities, allows me to better assess potential new areas of interest outside the pulmonary veins in order to achieve a more comprehensive assessment of complex atrial arrhythmias like atrial fibrillation.”