Volta Medical Announces U.S. Label Expansion for Volta AF-Xplorer™ to Include Pivotal TAILORED-AF Clinical Trial Data

• Volta Medical Secures U.S. Label Expansion for Volta AF-Xplorer Artificial Intelligence (AI) decision support system, clinically proven to help physicians treat underserved patients with persistent atrial fibrillation.

MARSEILLE, France, June 11, 2025 /PRNewswire/ — Volta Medical, a health technology company on a mission to treat the underserved complex atrial fibrillation (AF) patient population through the use of intelligent, AI solutions, today announced a significant update to the U.S. labeling of its flagship system, Volta AF-Xplorer. The AF-Xplorer delivers real-time, AI-driven insights to electrophysiologists, enabling more patient-specific decision-making in catheter ablation procedures treating AF. Labeling will now include the groundbreaking clinical data from the landmark TAILORED-AF trial which showed significantly improved long-term outcomes in the treatment of persistent AF compared to standard-of-care. Persistent AF is among the most challenging cardiac arrhythmias and represents 3/4 of all patients suffering from AF. However, only 1/3 of catheter ablations are performed on this more progressed disease state, resigning many to live with the debilitating disease. ^1,2

TAILORED-AF is a prospective, multicenter, randomized controlled trial comparing standard of care to the Volta AF-Xplorer AI-guided tailored ablation. Results are compelling: in the mITT population 88% of patients in the tailored arm were free from AF at 12 months, compared to just 70% of patients treated with standard pulmonary vein isolation (p<0.0001). The Volta AF-Xplorer is the first system in the history of electrophysiology to demonstrate level one evidence of improved efficacy outcomes for persistent AF patients. The study was published in Nature Medicine earlier this year. https://www.nature.com/articles/s41591-025-03517-w

“This label expansion is an important step for Volta Medical, and for millions of patients living with persistent AF,” said Theophile Mohr Durdez, CEO and co-founder of Volta Medical. “Clinical evidence now supports that Volta AF-Xplorer can assist physicians in improving outcomes for a vast and challenging arrhythmia population.”

For access to the new labeling, visit our website.

About Atrial Fibrillation

The American Heart Association (AHA) defines atrial fibrillation (AF) as a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications.³ Approximately 33 million patients worldwide are living with AF.^4,5 Even though untreated AF doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke, many patients are unaware that AF is a serious condition.

About TAILORED-AF

TAILORED-AF is a prospective, multicenter, randomized controlled clinical trial designed to evaluate whether a personalized ablation strategy using the AI-driven AF-Xplorer system improves outcomes for patients with persistent AF. In the modified intention-to-treat population, 88% of patients in the tailored ablation arm were free from AF at 12 months (with or without antiarrhythmic drugs), compared to 70% in the PVI-only group (p < 0.0001). Acute AF termination occurred in 66% of procedures using AF-Xplorer versus 15% in the control group. Secondary endpoints further support the approach. At 12 months, more patients in the tailored ablation arm were free from any atrial arrhythmia after one or two procedures, with or without the use of antiarrhythmic medications following a 3-month blanking period (76% vs. 71%), though this difference was not statistically significant. Additionally, the proportion of patients free from any atrial arrhythmia after one procedure (with or without antiarrhythmic medications after the blanking period) was the same in both groups (60%).

About Volta Medical

Volta Medical is a health technology company developing artificial intelligence software solutions with the aim of assisting cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. Founded by three physicians and a data scientist in 2016 in Marseille, France, the company’s mission is to improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data. The Volta AF-Xplorer is a digital AI companion designed to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs) known as spatio-temporal dispersed EGMs during AF and atrial tachycardia procedures. The Volta AF-Xplorer has been engineered for versatility and its use has been demonstrated with the most popular AF mapping and recording systems, as well as with the most common ablation modalities. The solution is U.S. FDA 510(k) cleared and European CE Marked. Volta Medical has created the therapy awareness program “AI for AF” designed to educate the underserved AF patient community, for more information, visit www.aiforafib.com.

Media Contact
Molly Megna, Sr. Marketing Manager
Volta Medical
molly.megna@volta-medical.com

References

1. “Efficacy of Dofetilide in the Treatment of Atrial Fibrillation-Flutter in Patients With Reduced Left Ventricular Function” Ole D. Pedersen, et al.
2. Kirchhof P, Calkins H. Catheter ablation in patients with persistent atrial fibrillation. Eur Heart J. 2017 Jan 1;38(1):20-26. doi: 10.1093/eurheartj/ehw260. Epub 2016 Jul 7.
3. https://www.heart.org/en/health-topics/atrial-fibrillation [last accessed June 9, 2023]
4. Colilla S, Crow A, Petku W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol 2013; 112:1142–1147. DOI: 10.1016/j.amjcard.2013.05.063
5. https://kompetenznetz-vorhofflimmern.de/en [last accessed June 9, 2023]

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SOURCE Volta Medical