AcQMap 8, Acutus Medical’s Innovative Suite of Software Upgrades, Receives FDA Clearance and CE Mark

Rhea-AI Summary

Acutus Medical (Nasdaq: AFIB) has announced FDA clearance and CE Mark approval for its software suite, AcQMap 8, which enhances the mapping of complex atrial arrhythmias. Key features include the AcQTrack algorithm that identifies abnormal conduction patterns and the SlowZone Locator, which maps areas of slow conduction. Clinical data shows targeting these patterns increases sinus rhythm success rates. AcQMap 8 integrates with existing systems, advancing arrhythmia treatments and improving patient outcomes.

Positive

• FDA clearance and CE Mark approval for AcQMap 8.
• Introduction of AcQTrack™ and SlowZone™ Locator algorithms to enhance mapping.
• Clinical trials indicate ninefold increase in patients achieving sinus rhythm after targeted ablation.

Negative

• None.

Enhanced Software Automatically Identifies Regions of Interest During the Treatment of Complex Atrial Arrhythmias

CARLSBAD, Calif., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Acutus Medical, Inc. (Nasdaq: AFIB) (“Acutus”), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced its innovative suite of software upgrades, known collectively as AcQMap 8, has received FDA clearance and been awarded CE Mark. AcQMap 8 introduces advanced 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.¹ The software upgrade also features a series of procedural workflow enhancements and seamless integration of Acutus’ therapeutic ablation technologies, where currently available.

Unique to Acutus’ full chamber non-contact mapping technology, which is capable of mapping individual beats in real-time, the AcQTrack mapping algorithm is engineered to automatically identify and analyze the presence of three abnormal conduction patterns (focal, partial-rotational and irregular) often associated with atrial fibrillation (AF). In clinical trials such as UNCOVER AF, when three to four of these abnormal conduction patterns were targeted for ablation, patients were nine times more likely to be in sinus rhythm after one year.¹ AcQTrack functions as an innovative tool that can fit seamlessly into electrophysiologists’ diagnostic workflows and aid in their visual assessment of propagation history maps. Acutus will commence the rollout of AcQMap 8 immediately, update its current installed base of consoles and integrate AcQMap 8 into all new installations.

“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 Prof. Tim Betts, M.D., Oxford University Hospitals NHS Foundation Trust. “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. 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. It is the first and only mapping algorithm that identifies consistent areas of slow conduction over the entire atrium. With the SlowZone Locator, physicians create one or more maps in the atria, which the algorithm then combines into one composite map for analyzing areas of consistent slow conduction in each patient.

“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, M.D., Penn State Health, Hershey, Penn. “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’re looking forward to working with this technology and continuing our pursuit of more individualized therapy approaches for our patients.”

AcQMap 8’s software enhancements also facilitate the seamless integration of Acutus’ AcQBlate FORCE Sensing Ablation Catheter and System* into the AcQMap system, enabling complete visualization and configuration of ablation procedures directly on the AcQMap system’s user interface.

“Our goal is to give physicians the tools they need to efficiently and effectively treat complex arrhythmias like atrial fibrillation,” said Vince Burgess, President and CEO, Acutus Medical. “We continue to push the boundaries of what’s possible in the EP lab and take significant technological strides designed to improve patients outcomes. AcQMap 8’s unique automated mapping algorithms and functionalities are a much-needed next step as we continue to drive innovation in the electrophysiology space and help physicians create optimized and personalized treatment strategies for all of their patients.”

To learn more about Acutus Medical’s complete portfolio of diagnostic, access and therapy products, please visit https://acutusmedical.com.

*AcQBlate FORCE is currently CE Marked. CAUTION: The AcQBlate FORCE Sensing Catheter and System are investigational devices and are limited by United States law to investigational use.

References
¹Willems, et al. “Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping – UNCOVER AF Trial.” Circulation: Arrhythmia and Electrophysiology. Vol. 12, No. 7, 2019.

About Acutus Medical
Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad, California.

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US Media Contacts
Holly Windler
(619) 929-1275
holly.windler@acutus.com

Levitate
(260) 408-5383
acutus@levitatenow.com

Investor Contact
Caroline Corner
(415) 202-5678
caroline.corner@westwicke.com

Photos accompanying this announcement are available at

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FAQ

What is Acutus Medical's AcQMap 8?

AcQMap 8 is a software suite recently approved by the FDA and CE Mark that enhances the mapping of complex atrial arrhythmias.

How does AcQMap 8 improve arrhythmia treatment?

It introduces advanced algorithms like AcQTrack and SlowZone Locator, which identify abnormal conduction patterns and areas of slow conduction respectively.

What are the benefits of AcQMap 8 based on clinical trials?

Clinical trials show that targeting specific abnormal conduction patterns can increase the likelihood of patients achieving sinus rhythm by nine times.

Which company announced the FDA clearance for AcQMap 8?

Acutus Medical announced the FDA clearance and CE Mark approval for its AcQMap 8 software.

When was AcQMap 8 approved?

AcQMap 8 received FDA clearance and CE Mark approval on August 11, 2021.