Volta Medical has received the US Food and Drug Administration (FDA) approval for Volta AF-Xplorer to evaluate the complex AF and atrial tachycardia (AT) procedures.

The French health technology company is engaged in developing artificial intelligence (AI)-based solutions for the treatment of complex cardiac arrhythmias, such as atrial fibrillation (AF).

Volta AF-Xplorer is an AI companion that uses a machine and deep learning-based algorithm trained on a large database of EGMs, annotated by expert electrophysiologists.

It enables a real-time, standardised approach to target dispersed EGMs.

The software upgrade features an enhanced integration with Abbott Laboratories’ EnSite X mapping system, said the health technology company.

Its automated Volta ‘regions of interest’ tagging capabilities will provide an improved workflow.

In addition, the AI software is compatible with Biosense Webster’s Octaray multi-polar mapping catheter, said Volta Medical.

Volta Medical CEO and co-founder Theophile Mohr-Durdez said: “There is a critical need for new ways to quickly and accurately identify abnormal electrograms (EGMs) for cardiac electrophysiologists to optimise their ablation strategy.

“Volta AF-Xplorer offers a tailored and intuitive workflow while allowing physicians to use their preferred mapping system and catheter.

“Volta AF-Xplorer assists physicians in the treatment of complex AF cases by providing real-time access to expert electrophysiologist techniques for detecting dispersed EGMs, suspected drivers of AF.”

In a previously published clinical trial, Volta’s AI solution has shown its ability to standardise the use of dispersed EGMs to guide ablation and achieve clinical outcome measures.

The solution also resulted in freedom from arrhythmia after 12 months, which meaningfully exceeds conventional outcomes.

Volta has recently completed enrolment in TAILORED-AF, the international multicentre randomised controlled trial of its customised VX1 AI software-guided ablation strategy.

TAILORED-AF evaluated pulmonary vein isolation plus Volta’s guided ablation compared to conventional pulmonary vein isolation in 374 patients with long-standing persistent AF.

The primary endpoint of the study is the absence of documented AF episodes greater than 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after the ablation procedure.

The secondary endpoints include the absence of AF and atrial tachycardia (AT) episodes after a 12-month period, following one or more procedures, as well as safety.

Volta said that the results from the TAILORED-AF trial are expected in 2024.