Acutus receives FDA and CE mark approvals for AcQMap 8

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Acutus Medical has received US Food and Drug Administration (FDA) and CE mark clearance for its suite of software upgrades known collectively as AcQMap 8. The upgrades introduce new mapping algorithms into Acutus’ foundational technology, the AcQMap 3D imaging and mapping system.

These algorithms—including AcQTrack and the SlowZone locator (composite maps)—are designed to quickly highlight regions of interest during the mapping and ablation of complex atrial arrhythmias, the treatment of which has been shown to significantly improve patient outcomes. The software upgrade also features a series of procedural workflow enhancements and seamless integration of Acutus’ therapeutic ablation technologies, where currently available.

“We are 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 (Oxford University Hospitals NHS Foundation Trust, Oxford, UK). “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 (AF). Algorithms like AcQTrack further extend my confidence to determine and execute treatment strategies specific to each individual patient, which has the potential to significantly improve patient outcomes.”

In addition to AcQTrack, the SlowZone Locator algorithm represents a pioneering advancement in substrate mapping. This identifies consistent areas of slow conduction over the entire atrium.

“I believe these algorithmic functions will have a significant influence on our overall treatment strategies, particularly in complex arrhythmia cases like atrial fibrillation,” said Sarah Hussain, (Penn State Health, Hershey, USA). “To be able to clearly see abnormal conduction patterns associated with AF while also having the opportunity to combine several full-chamber maps could provide us with brand new insights about the mechanisms of these complex atrial arrhythmias. We are looking forward to working with this technology and continuing our pursuit of more individualised therapy approaches for our patients.”


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