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September 18, 2020

FDA clears Acutus Medical’s 3D imaging and mapping catheter

Acutus Medical has secured FDA 510(k) clearance for its second-generation AcQMap 3D imaging and mapping catheter for atrial arrhythmias.

Acutus Medical has secured FDA 510(k) clearance for its second-generation AcQMap 3D imaging and mapping catheter for atrial arrhythmias.

This flagship 3D mapping and navigation catheter features 48 ultrasound transducers to create the anatomical geometry and 48 engineered electrodes for electrical activation patterns to be displayed along the inner surface of the heart.

AcQMap, designed to be inserted into the left and right atrium, is compatible with 0.035in guidewire.

Furthermore, it is allegedly the only existing integrated high-resolution ultrasound-based imaging and non-contact mapping catheter with the ability to collect cardiac imaging information, along with cardiac activation mapping.

Additional benefits including better anatomy reconstruction, quicker acquisition times are offered by the second-generation catheter. It also features a reusable and sterilisable cable for use up to ten times, allowing healthcare systems to better save costs.

The adaptability of the AcQMap System enables physicians to map all types of atrial arrhythmias including simple and complex, spontaneous, repetitive and chaotic, the company said.

Furthermore, the high definition maps delivered by the AcQMap catheter help physicians to spot ablation targets outside the pulmonary veins and strategically organise a patient-specific ablation strategy.

The company claimed the physicians can efficiently map any arrhythmia in less than three minutes, ablate and then remap again to evaluate therapy effectiveness, using its second-generation AcQMap.

Acutus Medical president and CEO Vince Burgess said: “At Acutus, we pride ourselves on our continued and rapid cadence of bringing innovative, differentiated technologies to the market.

“We are committed to partnering with physicians to continually provide products and solutions to address physicians unmet needs.”

In May, Acutus Medical partnered with Biotronik to collaborate on electrophysiology-related products.

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