Volta AF-Xplorer™ II
AI Companion Technology for assessment of complex AF and AT
Company profile
Company profile
Volta Medical is a medical device company specializing in artificial intelligence solutions for cardiac electrophysiology, with a particular focus on complex atrial fibrillation (AF) and atrial tachycardia (AT). The company's mission is to aid in the assessment of complex arrhythmia pathologies through data-inspired AI technology. Volta has developed the VoltaPlex data collection and enrichment ecosystem for curated electrophysiology lab data, which feeds into a physician-validated machine learning methodology to support EP solutions. This framework has resulted in Volta's flagship product, Volta AF-Xplorer™ II, a Companion AI technology designed for real-time assessment of complex AF and AT. The system assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria, identifying areas exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia. Volta's technology addresses a critical clinical need: determining the right ablation approach for persistent AF, where clinical success rates in landmark studies are only approximately 50%. The company's AI can match the expertise of multi-year-trained electrophysiologists to analyze intracardiac atrial electrograms in real time and identify areas of interest potentially involved in the arrhythmia mechanism. Volta serves electrophysiologists and cardiac care providers treating complex substrate patients, including those with persistent AF, redo patients with pulmonary vein isolation, women with AF, and heart failure patients. The company has established one of the most ambitious clinical programs focused on the underserved complex AF patient population, including the landmark TAILORED-AF randomized controlled trial published in Nature Medicine.
Company description Volta Medical official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
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Company milestones
TAILORED-AF randomized controlled trial published in Nature Medicine (2025), RESTART Trial completed (2026), FDA clearance obtained, CE mark obtained, global headcount expected to reach nearly 100 team members by end of 2023
Partnerships
No partners are currently listed.
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
AI Companion Technology for assessment of complex AF and AT
Data Collection & Enrichment Process for EP lab data
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Heart rhythm · May 1, 2026
Targetable atrial tachycardias after artificial intelligence-guided ablation of persistent atrial fibrillation.Heart rhythm · Mar 1, 2026
Artificial intelligence-guided personalized ablation improves freedom from atrial arrhythmia in heart failure: A sub-analysis of the TAILORED-AF trial.Heart rhythm O2 · Feb 1, 2026
The use of a contact force-sensing very-high-power short-duration radiofrequency catheter leads to significant efficiency improvement for dispersion-based ablation of persistent atrial fibrillation.Heart rhythm O2 · Nov 1, 2025
Women with persistent atrial fibrillation need more than pulmonary vein isolation: personalised extra-pulmonary vein ablation strategy vs. pulmonary vein isolation alone in the TAILORED-AF trial.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · Oct 31, 2025
Artificial intelligence for individualized treatment of persistent atrial fibrillation: a randomized controlled trial.Nature medicine · Apr 1, 2025
Clinical validation
No linked records are currently available.
Regulatory
K251518 · 510k · Sep 12, 2025
Volta AF-XplorerK243812 · 510k · May 9, 2025
Volta AF-XplorerK232616 · 510k · Sep 27, 2023
VX1+K223516 · 510k · Jan 21, 2023
VX1K201298 · 510k · Sep 16, 2020
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Addresses persistent AF where landmark studies show only ~50% success
Significantly increased 12-month arrhythmia-free survival in women with persistent AF after one procedure
High freedom from arrhythmia in redo patients with recurrent AF despite durable PVI
Improved quality of life in redo patient population
Greatest benefit in heart failure patients with NYHA class III symptoms
AI-guided dispersion ablation for redo patients with recurrent AF despite durable pulmonary vein isolation
High freedom from arrhythmia, improved quality of life, and favorable safety profile in challenging redo population
AI-guided tailored ablation for persistent atrial fibrillation patients compared to conventional PVI treatment
Significantly increased 12-month arrhythmia-free survival after one procedure; greater benefit in patients with longer AF duration and advanced atrial remodeling
Artificial intelligence software standardization of electrogram-based ablation outcome for persistent atrial fibrillation
Robust validation of AI-based solution achieving standardized outcomes
Personalized AI-guided ablation for heart failure patients with AF across all NYHA classes
Improved freedom from AF/AT compared with PVI across all NYHA classes; greatest benefit in NYHA class III patients with higher FFAF/AT after one or two procedures
AI-guided tailored ablation for women with persistent AF who typically have more extensive atrial substrate and higher recurrence rates
Significantly increased 12-month arrhythmia-free survival after one procedure; potential reduction in sex-based disparities in outcomes
05 · Leadership
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06 · Company updates
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07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies applying AI to cardiovascular disease detection, ECG/EKG analysis, heart failure management, cardiac imaging, arrhythmia detection, or cardiovascular risk assessment. Includes AI-powered cardiac diagnostics, non-invasive hemodynamic monitoring, and tools for early detection and personalized management of heart conditions.
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