French healthtech company Volta Medical is turning up the voltage to broaden use of its Volta AF-Xplorer mapping software, which clinicians use to treat persistent atrial arrhythmia, the most common type of abnormal rapid heartbeat.
The company reached a major milestone with the recent US Food and Drug Administration labeling expansion of its AF-Xplorer, based on compelling data from a recently published clinical trial. The labeling expansion, announced in June, builds on the product’s 2020 510(k) clearance.

Theophile Mohr-Durdez, CEO of Volta Medical, explained the labeling expansion is important to support discussions with clinicians, payers and health systems to show the product’s “value in real-world treatment strategies.”
“Importantly, we have been able to remove the previous disclaimer from the ‘Instructions for Use’ that stated the clinical significance of using Volta AF-Xplorer to identify specific electrical signals had not been established by clinical studies,” Mohr-Durdez told Medtech Insight during a recent interview.
Mohr-Durdez is confident that the now-established clinical evidence will open the door for more physicians to confidently use the software and for more people to undergo catheter ablations, an electrophysiology procedure during which a catheter is inserted into the blood vessel and guided to the heart. The catheter uses energy to create tiny scars in the heart tissue, blocking the abnormal electrical pathways that cause irregular heartbeat. The success rate remains between 60% and 85% after one or two procedures, according to UC San Diego Health. For persistent or long-standing A-Fib, success rates are often on the lower end.
Key Takeaways
- Volta secured an FDA labeling expansion for its AF-Xplorer software based on positive TAILORED-AF study results. This key milestone provides the clinical evidence needed to support broader adoption of its AI-guided mapping system for persistent A-fib ablation.
- Volta has filed for FDA clearance of its next-generation AF-Xplorer II, which features improved algorithms and deeper data training.
- With adoption already underway at 15 US centers, Volta is ramping up a focused US commercialization strategy.
Meanwhile, Volta has already filed for FDA clearance of its second-generation software, Volta AF-Xplorer II, with expected clearance by year-end. Mohr-Durdez pointed to improvements such as training on a much larger set of real-world data and advanced algorithms that help physicians identify key areas to target. The software is integrated with partner GE HealthCare’s latest electrophysiology recording system to improve signal quality and streamline lab workflow, he said.
“This supports more precise procedures, reduces unnecessary ablation and helps preserve healthy heart tissue,” he said.
Critical Study Findings
Findings from Volta Medical’s TAILORED-AF study showed that tailored cardiac ablation guided by AI resulted in significantly improved long-term outcomes compared to standard isolations of the pulmonary vein among 374 patients with persistent A-fib.
Among those who received both types of ablations in a single procedure, 88% treated with Volta’s ablation were free from A-fib symptoms at 12 months, versus 70% of patients who underwent pulmonary vein isolation alone, or standard care. Researchers from the study seemed impressed with the results, noting “this individualized AI-driven, electrocardiogram-guided ablation played a crucial role in eliminating AF and in achieving superiority over the standard pulmonary vein isolation-only procedure.”
However, during a session at the HRS 2025 meeting, held April 24-25 in San Diego, Stanford Medicine cardiologist Tina Baykaner pointed to the limitation of the AI-based approach of requiring longer procedure times but expressed optimism that the AI can be optimized to provide better long-term outcomes.
Mohr-Durdez acknowledged that the AI-based approach adds procedure time but explained that there are some 25 different techniques being used by electrophysiologists today with complex patients While some of these techniques add time, others do not.
“There is a vast heterogeneity of practices in A-fib ablation, so it’s very hard to really compare, but I would say on average yes, we are increasing the time of the procedure but for the benefit of improving the efficacy and increasing the volume maybe of patients by bringing new patients to the lab,” Mohr-Durdez said.
Volta’s latest solution, AF-Xplorer, received FDA clearance for assessing complex A-fib and atrial tachycardia procedures in 2022, followed by the CE mark in February 2024. The software reads electrocardiogram data from commercially available cardiac mapping systems to detect areas of spatiotemporal dispersion, which are patterns believed to drive persistent A-fib. These areas of interest are then flagged visually and in some cases automatically tagged.
Mohr-Durdez said that the company continues its targeted commercialization effort to selectively partner with physicians at tertiary and community hospitals. The software is being used at 15 centers across the US including West Virginia University Medicine in Morgantown, W.V., and the Mayo Clinic.
In Europe, the software is commercially available in key centers in countries including Germany, France and the Netherlands.
In the US, Volta plans to ramp up commercialization efforts with a dedicated sales force in the US. The software will be sold through a subscription model with the pricibasedts ability to “improve efficacy for this complex patient population,” he said, declining to share further details.
Global Market
According to LSI’s Global Surgical Procedures Volumes database, heart rhythm management procedures including ablation are seeing significant growth. In 2024, about 1.4 million cardiac ablation procedures were performed globally. Over the next five years, the volume of heart rhythm management procedures is expected to rise, driven by a growing prevalence of heart conditions, the adoption of new technologies and an aging population. LSI expects the market for mapping and ablation consoles and catheters to grow at a CAGR of 9.3% from 2024 to 2029.
Mohr-Durdez, a data scientist, cofounded Volta in Marseille in 2016 with three physician scientists and has raised over €90m across three main funding rounds to support the development and commercialization of its AI software solutions. In 2018, Volta raised €2.6m in seed funding, led by Groupe Pasteur Mutualité, a French mutual insurance company focused on healthcare professionals, followed two years later with a Series A round of €23m, led by Gilde Healthcare, a European healthcare investor, with continued participation from Groupe Pasteur Mutualité. In January 2023, it closed a €36m series round led by Vensana Capital, a US-based medtech growth equity firm, with participation from Lightstone Ventures and continued support from Gilde Healthcare.
While catheter ablation for A-fib is reimbursed by Medicare and private insurers, the use of advanced technologies like AF-Xplorer is not separately reimbursed. This means that Volta will need to show that AF-Xplorer offers clear advantages such as lowering costs, improving outcomes or reducing complications for hospitals and physicians to adopt it widely.
“[Catheter ablation] is one of the most profitable verticals in medicine in the US,” Mohr-Durdez said. “To increase their [clients’] overall profit, the technology needs to increase their [procedure] volume.”