Volta Medical has announced CE mark for its Volta AF-Xplorer, an artificial intelligence (AI) companion that is cleared in the USA for the real-time manual or automatic annotation of spatiotemporal dispersions during AF and atrial tachycardia (AT) procedures.
Volta’s AF-Xplorer is the enhanced version of Volta’s VX1 device. This step will enable sales and distribution of the new product in the European Union (EU), the company says in a press release.
“We are pleased that Volta’s AF-Xplorer is now available in the EU to assist electrophysiologists in the treatment of patients with atrial fibrillation,” said Theophile Mohr-Durdez, Volta Medical CEO and co-founder. “The launch of AF-Xplorer will accelerate our growth in the EU market.”
The Volta AF-Xplorer employs an algorithm powered by machine and deep learning, which has been trained on an extensive database of electrograms (EGMs), that have been annotated by electrophysiologists. This methodology facilitates a standardised approach to pinpointing what is known as spatiotemporal dispersed EGMs, a suspected source of AF, the company’s press release adds.
TAILORED-AF, an international, multicentre, randomised controlled trial, comparing conventional pulmonary vein isolation to pulmonary vein isolation plus Volta’s guided ablation with Volta VX1, enrolled 374 patients with persistent and long-standing persistent AF. Results from TAILORED-AF are expected later this year.
Volta’s AF-Xplorer also received U.S. Food and Drug Administration (FDA) clearance in January 2023 for the real-time manual or automatic annotation of spatiotemporal dispersions during AF and atrial tachycardia (AT) procedures.
“We are excited about the potential impact of AF-Xplorer for patients with persistent, drug-resistant AF,” said Tom De Potter, an electrophysiologist at OLV Hospital (Aalst, Belgium). “The AI companion offers a more personalised and precise approach by pinpointing optimal ablation locations in real time.”
Volta is currently enrolling patients in Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion (RESTART), an interventional clinical trial to be conducted at sites across the USA and select EU countries, evaluating the use of Volta’s AI companion solution in recurrent-AF patients who failed previous ablations.
