Volta AF-Xplorer II
Overview
Volta Medical is a health technology company dedicated to revolutionizing the care for complex atrial fibrillation (AF) and atrial tachycardia (AT) patients through breakthrough artificial intelligence (AI) solutions. Founded in 2016 by a data scientist and three electrophysiologists in Marseille, France, Volta Medical’s mission is to improve patient outcomes by developing cutting-edge, data-driven solutions trained on vast procedural datasets.
The Volta AF-Xplorer™ II is the company’s flagship product, a next-generation digital AI companion designed to assist electrophysiologists. It provides real-time identification of spatio-temporal dispersed electrograms (EGMs) during AF and atrial tachycardia procedures. This AI companion technology aims to simplify the real-time assessment of complex AF, offering high stability analysis to provide physicians with an objective method for identifying regions of interest.
Engineered for versatility, AF-Xplorer II integrates seamlessly with leading AF mapping and recording systems and is compatible with most common ablation modalities, including expanded catheter compatibility with devices like the Medtronic Sphere-9™ mapping and ablation catheter. It also offers integration with systems such as the GE HealthCare CardioLab™ AltiX AI.i recording system for a streamlined workflow.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI Companion Technology for complex AF and AT assessment
- Real-time identification of spatio-temporal dispersed electrograms (EGMs)
- High stability analysis for objective identification of regions of interest
- Expanded catheter compatibility, including Medtronic Sphere-9u2122 mapping and ablation catheter
- Integration with GE HealthCare CardioLabu2122 AltiX AI.i recording system
- Powered by machine and deep learning algorithms trained on diversified EGM database
- Analysis of spatio-temporal dispersed EGMs based on dispersion time and intensity stability
- Booster Mode for increased software sensitivity during AT or slow AF
- Automated tagging of regions of interest (with compatible mapping systems like EnSite Xu2021)
Use Cases
- Assisting electrophysiologists during catheter-ablation procedures for complex arrhythmias
- Real-time assessment of complex Atrial Fibrillation (AF) and Atrial Tachycardia (AT)
- Identifying areas of interest potentially involved in arrhythmia mechanisms
- Streamlining procedures and enhancing efficiency in the EP lab
What Physicians Need to Know
Volta AF-Xplorer II offers electrophysiologists a powerful AI-driven tool for real-time identification of arrhythmia drivers in complex atrial fibrillation and atrial tachycardia, potentially improving ablation outcomes and procedural efficiency. Its advanced dispersion analysis, including high stability analysis, provides objective data to guide ablation strategies. Physicians should leverage its seamless integration with existing mapping and recording systems to optimize workflow and consider its use particularly in persistent AF and redo cases where traditional approaches have limited success. The 'Booster Mode' can be valuable during slow AF or AT to enhance sensitivity.
Volta AF-Xplorer II is engineered for versatility, integrating seamlessly with leading AF mapping and recording systems and compatible with most common ablation modalities, including PFA catheters. Key integrations include the GE HealthCare CardioLabu2122 AltiX AI.i recording system for a unified workspace and enhanced digital communication, and compatibility with the Medtronic Sphere-9u2122 mapping and ablation catheter. It supports bidirectional digital communication with specific 3D mapping systems (e.g., EnSite X) for automatic tagging, simplifying EP lab workflow and reducing hardware footprint.
Details
| Category | Cardiology AI, Surgical AI |
| Pricing | Contact for pricing |
| Deployment | Integrated with existing EP lab systems (mapping and recording systems) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The Volta AF-Xplorer™ II system is a Class IIa Medical Device that is U.S. FDA 510(k) cleared (K251518) and European CE Marked. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology |
What the Web Says
Volta AF-Xplorer II is an AI-powered solution designed to assist electrophysiologists in real-time assessment and treatment of complex atrial fibrillation (AF) and atrial tachycardia (AT) during ablation procedures. It utilizes machine and deep learning algorithms trained on a large database of electrograms (EGMs) to identify spatio-temporal dispersed EGMs, which are indicative of arrhythmia drivers. The system aims to standardize EGM interpretation, streamline workflows, and potentially improve long-term outcomes for patients, especially those with persistent and long-standing AF.
Overall: PositiveStrengths
- Real-time identification of dispersed electrograms (EGMs) and arrhythmia drivers.
- Improved signal quality and clarity, even in noisy lab environments.
- Streamlined workflow and simplified mapping process due to side-by-side display and integration with existing systems.
- Enhanced dispersion stability analysis for objective identification of regions of interest.
- Expanded compatibility with major EP recording systems, 3D navigation systems, and various mapping and ablation catheters, including PFA catheters.
- Demonstrated superior efficacy in clinical trials for persistent and long-standing AF compared to conventional ablation methods.
Limitations
- Procedure and ablation times can be longer compared to PVI-only methods.
- Relatively new technology, so long-term data beyond current studies is still accumulating.
- Requires integration with existing EP lab equipment, which might involve initial setup and compatibility considerations.
- While aiming to standardize, physician interpretation of raw electrograms remains important.
- No specific contraindications mentioned, but general risks associated with cardiac ablation procedures apply.
Based on reviews from: Volta Medical Official Website, HMP Global Learning Network (EP Lab Digest), Cardiac Rhythm News, PR Newswire, accessdata.fda.gov, BioWorld, TipRanks.com, Elion, AI in Medicine Journal Club, BioSpace, AIS Health, Fierce Biotech, Medical Device and Diagnostic industry
Last updated: 2026-07-19
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