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Volta Medical Announces FDA Clearance of Volta AF-Xplorer™ Software to Simplify Complex Atrial Fibrillation Procedures

Friday, May 19, 2023

Volta Medical has announced that its AI solution, Volta AF-Xplorer™, has received clearance from the U.S. Food and Drug Administration (FDA). Volta AF-Xplorer is designed to assist electrophysiologists in the treatment of complex cardiac arrhythmias, including atrial fibrillation (AF) and atrial tachycardia (AT). The company will be showcasing the AI companion at the 44th annual Heart Rhythm 2023 event, both in-person in New Orleans, LA, and virtually from May 19-21.

The CEO and co-founder of Volta Medical, Theophile Mohr-Durdez, highlighted the need for new methods to identify abnormal electrograms (EGMs) accurately and efficiently in order to optimize ablation strategies. Volta AF-Xplorer aims to address this need by offering a tailored and intuitive workflow that allows physicians to use their preferred mapping system and catheter. The AI companion provides real-time access to expert electrophysiologist techniques for detecting dispersed EGMs, which are suspected drivers of AF.

Volta AF-Xplorer employs a machine and deep learning-based algorithm trained on a large database of EGMs that have been annotated by expert electrophysiologists. This approach enables real-time and standardized targeting of dispersed EGMs. The software upgrade also includes an enhanced integration with Abbott Laboratories' EnSite X mapping system, resulting in improved workflow through automated tagging capabilities of Volta's "regions of interest." Additionally, the software is compatible with Biosense Webster's Octaray multi-polar mapping catheter, a popular option among physicians.

A previously conducted multi-center clinical study demonstrated that Volta's solution can standardize the use of dispersed EGMs for guiding ablation and achieve clinical outcome measures that exceed conventional outcomes. The study showed meaningful improvement in freedom from arrhythmia after 12 months. Volta has recently completed enrollment for TAILORED-AF, a global multicenter randomized controlled trial comparing conventional pulmonary vein isolation to pulmonary vein isolation combined with Volta's guided ablation in 374 patients with persistent and long-standing persistent AF.

During the Heart Rhythm 2023 event, Volta Medical will present a Heart Rhythm Theater session titled "Could Targeting AI-Driven Dispersion EGMs Be the Missing Link for Better Persistent AF Outcomes?" The session will include a review of Volta cases, current and future clinical evidence, and considerations regarding AI. The presentation will be moderated by Dr. John Hummel from Ohio State University, with contributions from Drs. Devi Nair, Jose Osorio, Benjamin D'Souza, and Prof. Isabel Deisenhofer.

In addition, Volta will present a poster titled "Biatrial Characterization of AI Identified Spatiotemporal Dispersion in Persistent Atrial Fibrillation" during the event. The poster highlights the unique patterns of dispersion EGMs found in each patient, as analyzed in the previously published Ev-AIFib study.

Attendees of the Heart Rhythm 2023 event can visit Volta Medical's booth (#1340) to experience a demonstration of the Volta AF-Xplorer software.

Heart Rhythm 2023, hosted by the Heart Rhythm Society, serves as a platform for leading clinicians, scientists, researchers, and innovators to exchange groundbreaking scientific advancements aimed at improving the care of arrhythmia patients.

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