Marseille (France), June 11, 2025 – Volta Medical, a health technology company on a mission to treat the underserved complex atrial fibrillation 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 atrial fibrillation (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 arrhythmia 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.
À propos de la fibrillation auriculaire
L'American Heart Association (AHA) définit la fibrillation atriale (FA) comme un tremblement ou un battement de cœur irrégulier (arythmie) qui peut entraîner des caillots sanguins, un accident vasculaire cérébral, une insuffisance cardiaque et d'autres complications cardiaques.3 Environ 33 millions de patients dans le monde vivent avec la FA.4,5 Même si la FA non traitée double le risque de décès liés au cœur et est associée à un risque 5 fois plus élevé d'accident vasculaire cérébral, de nombreux patients ne sont pas conscients que la FA est une affection grave.
À propos de 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%).
À propos de Volta Medical
Volta Medical est une entreprise de technologie de la santé qui développe des solutions logicielles d'intelligence artificielle dans le but d'aider les électrophysiologistes cardiaques pendant les procédures de traitement des arythmies afin d'améliorer les résultats cliniques pour les patients. Fondée par trois médecins et un data scientist en 2016 à Marseille, France, la mission de l'entreprise est d'améliorer la prise en charge des arythmies cardiaques en développant des dispositifs médicaux de pointe, basés sur des données et entraînés sur de vastes bases de données de données procédurales. Le Volta AF-Xplorer est une solution d'IA conçue pour aider les cardiologues à identifier en temps réel des électrogrammes (EGM) anormaux spécifiques, appelés EGM dispersés spatio-temporels, pendant les procédures de FA et de tachycardie atriale. Le Volta AF-Xplorer a été conçu pour être polyvalent et son utilisation a été démontrée avec les systèmes de cartographie et d'enregistrement de la FA les plus populaires, ainsi qu'avec les modalités d'ablation les plus courantes. La solution a reçu l'autorisation 510(k) de la FDA américaine et le marquage CE. Volta Medical a créé le programme de sensibilisation thérapeutique "AI for Persistent AF" conçu pour éduquer la communauté de patients mal desservie atteints de FA. Pour plus d'informations, visitez www.aiforafib.com.
Contact presse
Molly Megna, Sr. Marketing Manager
Volta Medical
molly.megna@volta-medical.com
Références
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 [dernière consultation le 9 juin 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 [dernière consultation le 9 juin 2023]
