Volta AF-Xplorer

by Volta Medical  · Based in France → — AI Companion Designed for the Assessment of Complex AF & AT during ablation procedures.
Cardiology

Contact for pricing
Regulatory Status Disclosed

Overview

Volta AF-Xplorer is an AI-assisted mapping and decision-support system developed by Volta Medical for use during electrophysiology (EP) ablation procedures. It is specifically designed for the assessment and treatment of complex atrial fibrillation (AF) and atrial tachycardia (AT). The system leverages machine and deep learning algorithms to automatically detect and annotate dispersed electrograms (EGMs) in near real-time, which are indicative of arrhythmia’s drivers. It integrates seamlessly with most existing EP recording systems, 3D mapping/navigation systems, and mapping catheters, offering an intuitive workflow for electrophysiologists. The latest iteration, Volta AF-Xplorer II, further enhances analysis stability and expands compatibility with advanced catheters and recording systems like GE HealthCare’s CardioLab AltiX AI. The technology aims to standardize ablation strategies and improve clinical outcomes for patients with complex cardiac arrhythmias.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-assisted mapping and decision-support system for EP ablation procedures
  • Real-time detection and annotation of dispersed electrograms (EGMs)
  • Automated tagging of regions of interest (with compatible mapping systems like EnSite Xu2021)
  • Dispersion Indicator with color-coded electrogram dispersion levels (Red: highly dispersed, Orange: dispersed, Blue: non-dispersed)
  • Compatibility with most EP recording, 3D navigation systems, and mapping catheters (including PFA catheters)
  • Booster Mode to increase software sensitivity during Atrial Tachycardia (AT) or slow Atrial Fibrillation (AF)
  • Estimation of Reference Cycle Length and Mapping Cycle Length from real-time recordings
  • Simple User Interface for Real-Time Regions of Interest Identification
  • High stability analysis for dispersion time and intensity (Volta AF-Xplorer II)
  • Integration with GE HealthCare CardioLab AltiX AI recording system for streamlined workflow (Volta AF-Xplorer II)

Use Cases

  • Assessment of complex Atrial Fibrillation (AF) during ablation procedures
  • Assessment of Atrial Tachycardia (AT) during ablation procedures
  • Guiding catheter ablation procedures for persistent and long-standing AF
  • Real-time identification of spatio-temporal dispersed electrograms (EGMs)
  • Improving clinical outcomes for patients with cardiac arrhythmias
  • Standardizing electrogram-based ablation outcomes

What Physicians Need to Know

ECG/EKG Analysis Capability
Volta AF-Xplorer analyzes multipolar intra-cardiac atrial electrograms (EGMs) in real-time during atrial fibrillation (AF) and atrial tachycardia (AT) ablation procedures. It identifies specific abnormal electrograms known as spatio-temporal dispersed EGMs, which are considered drivers of AF.
Arrhythmia Detection Accuracy
The AI-powered system assists in the real-time identification of spatio-temporal dispersed EGMs during AF and AT procedures. The TAILORED-AF randomized clinical trial demonstrated that AI-guided ablation led to 88% of patients being free from AF at 12 months, significantly higher than the 70% in the standard pulmonary vein isolation group. Acute AF termination was achieved in 66% of procedures using AF-Xplorer, compared to 15% in the control group.
Cardiac Monitoring Integration
Volta AF-Xplorer is engineered for versatility and integrates seamlessly with leading AF mapping and recording systems, as well as common ablation modalities. Notable integrations include GE HealthCare's CardioLab AltiX AI.i EP recording system, offering a unified workspace and streamlined workflow. It also integrates with Abbott Laboratories' EnSite X mapping system, enabling automatic tagging of regions of interest, and has expanded compatibility with various mapping catheters, including Medtronic Sphere-9.
AHA/ACC Guideline Alignment
Volta Medical's mission is to improve cardiac arrhythmia management, aligning with the American Heart Association's (AHA) understanding of AF as a serious condition leading to various heart-related complications. The TAILORED-AF trial's results, demonstrating improved efficacy for persistent AF, provide clinical evidence supporting its role in advanced AF treatment strategies. The AI solution is also included in the latest consensus statement on atrial fibrillation ablation from leading international cardiac electrophysiology societies.
Real-Time Alert Capability
The system functions as an AI companion providing real-time identification and annotation of spatio-temporal dispersed electrograms on 3D anatomical and electrical maps of the heart. It supports real-time decision-making for electrophysiologists during complex AF and AT ablation procedures using machine learning and deep learning algorithms.
Physician Tip

Volta AF-Xplorer offers electrophysiologists a powerful AI-driven tool to objectively identify and target dispersed electrograms, which are implicated as drivers of atrial fibrillation, particularly in complex and persistent AF cases. This real-time guidance can standardize ablation strategies, enhance procedural precision, and potentially improve long-term patient outcomes, as demonstrated by the TAILORED-AF trial. The system aims to streamline workflow and reduce cognitive load during complex ablation procedures, allowing for more efficient and consistent treatment.

Volta AF-Xplorer is designed for broad compatibility within the electrophysiology lab. It integrates with most popular EP recording and 3D navigation systems, including GE HealthCare's CardioLab AltiX AI.i and Abbott Laboratories' EnSite X mapping system. This allows for features like automatic tagging of regions of interest and a unified workspace. The system also supports a wide range of mapping and ablation catheters, such as the Medtronic Sphere-9, ensuring flexibility in clinical practice.

Details

Category Cardiology AI, Surgical AI
Pricing Contact for pricing
DeploymentSoftware, integrated with existing electrophysiology lab hardware (e.g., EP recording systems, 3D navigation systems, mapping catheters).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

Volta AF-Xplorer is FDA cleared. The original VX1 system received FDA clearance in September 2020. The Volta AF-Xplorer (K243812) and the newer Volta AF-Xplorer II (K251518) are cleared to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.

Integrations
EHR Not specified
Specialties Cardiology

What the Web Says

Volta AF-Xplorer is an AI-assisted mapping and decision-support system used in electrophysiology (EP) ablation procedures for atrial fibrillation (AF) and atrial tachycardia (AT). It identifies dispersed electrograms (EGMs) in near real-time, which are believed to be drivers of AF. The system aims to standardize EGM interpretation and improve outcomes for complex AF patients, particularly those with persistent and long-standing AF.

Overall: Positive

Strengths

  • Improved signal quality and clarity, potentially reducing evaluation time.
  • Simplifies setup and streamlines the mapping process.
  • Demonstrated superior efficacy in treating persistent and long-standing AF compared to conventional ablation alone.
  • Compatible with major mapping catheters, navigation systems, and recording systems, allowing physicians to use their preferred tools.
  • Provides real-time identification of spatio-temporal dispersion areas, enhanced with advanced dispersion stability analysis.
  • Potential for improved outcomes in challenging patient populations, such as those with recurrent AF despite previous ablations.

Limitations

  • AI-guided ablation procedures may require longer procedural times.
  • The technology is not separately reimbursed, requiring Volta to demonstrate cost-effectiveness or other advantages for widespread adoption.
  • Some Reddit discussions about ablation experiences, while not specific to Volta AF-Xplorer, highlight potential post-procedure pain and recovery challenges.

Based on reviews from: Elion, HMP Global Learning Network, BioWorld, PR Newswire, BioSpace, TipRanks.com, AI in Medicine Journal Club, Cardiac Rhythm News, Fierce Biotech, accessdata.fda.gov, Reddit

Last updated: 2026-07-20

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Press & Coverage

Volta Medical (via PR Newswire)
Volta Medical Brings Volta AF-Xploreru2122 II to the U.S., Ushering in a New Era of AI in Ablation for Complex Atrial Fibrillation
Volta Medical announced the U.S. launch of its next-generation AI solution, the AF-Xplorer II system, designed to simplify real-time assessment of complex atrial fibrillation. The system offers high stability analysis, expanded catheter compatibility, and integration with GE HealthCare's CardioLabu2122 AltiX AI recording system.
2025-11
Volta Medical (via BioSpace)
Volta Medical's RESTART Trial Shows Promising Findings for AI Solutions in Recurrent Atrial Fibrillation
The RESTART trial demonstrated that Volta Medical's AI solution achieved 83% freedom from atrial fibrillation at 12 months after a single procedure in patients with recurrent AF and isolated pulmonary veins following prior ablation. These findings were published in Heart Rhythm.
2026-02
PR Newswire
Volta Medical Announces U.S. Label Expansion for Volta AF-Xploreru2122 to Include Pivotal TAILORED-AF Clinical Trial Data
Volta Medical announced a significant update to the U.S. labeling of its Volta AF-Xplorer, now including clinical data from the TAILORED-AF trial, which showed improved long-term outcomes for persistent AF compared to standard-of-care. This expansion provides crucial clinical evidence to support broader adoption of the AI-guided mapping system.
2025-06
Volta Medical
Volta Medical and GE HealthCare Announce Successful U.S. Launch of Joint AI-Driven Electrophysiology Solutions
Volta Medical and GE HealthCare successfully launched the first U.S. electrophysiology software developed through their Joint Development Agreement, integrating Volta Medical's AF-Xplorer II system with GE HealthCare's CardioLabu2122 AltiX AI recording system. This collaboration aims to enhance performance and streamline workflows for electrophysiologists.
2025-11
Volta Medical
Volta Medical Receives CE Mark for AF-Xploreru2122 Decision support solution to Simplify Complex Atrial Fibrillation Procedures
Volta Medical announced it received CE Mark approval for its Volta AF-Xploreru2122 under the new European Medical Device Regulation MDR 2017/745, enabling sales and distribution of the AI companion in the EU. The device assists electrophysiologists in real-time assessment of dispersed electrograms during AF and atrial tachycardia procedures.
2024-02
EP Lab Digest
Volta Medical Artificial Intelligence-guided Cardiac Ablation Procedure Improves Treatment of Atrial Fibrillation
Volta Medical announced the publication of the TAILORED-AF clinical trial in Nature Medicine, demonstrating that an AI-guided procedure for persistent atrial fibrillation, combined with conventional pulmonary vein isolation, resulted in better outcomes than PVI alone. This marks a significant advancement in interventional cardiology.
2025-02
AIS Health
Volta Files For US FDA Approval Of Next-Gen Cardio Mapping Software After Winning Labeling Expansion
Volta Medical has filed for FDA clearance of its next-generation AF-Xplorer II software, building on the recent FDA labeling expansion for its AF-Xplorer. The company is also ramping up its U.S. commercialization strategy, with adoption already underway at 15 U.S. centers.
2025-06
Ochsner Health
Ochsner Health offers AI-powered technology for atrial fibrillation
Ochsner Health is the first in Louisiana to implement Volta's AI-powered technology, the Volta AF-Xplorer, for atrial fibrillation procedures. This software assists physicians with real-time analysis of 3D heart maps during catheter ablation, enhancing treatment precision.
2025-09

Videos

Product demos, reviews, and walkthroughs for Volta AF-Xplorer.

View all on YouTube

Frequently Asked Questions

Volta AF-Xplorer is an AI-powered companion designed to assist electrophysiologists in real-time by identifying spatio-temporal dispersed electrograms (EGMs) during AF and atrial tachycardia (AT) ablation procedures. It uses machine and deep learning algorithms to automatically tag regions of interest on 3D anatomical and electrical maps, helping guide more precise and personalized ablation strategies.
Volta AF-Xplorer has received U.S. FDA 510(k) clearance and European CE Mark approval, indicating its compliance with relevant medical device regulations. The device is restricted by federal law to sale by or on the order of a physician, and users must comply with FDA requirements including registration, labeling, and good manufacturing practices.
Potential challenges include concerns about algorithmic bias, the quality of the data used for training, and the 'black box' nature of deep learning models. Additionally, successful widespread adoption may require addressing market acceptance, reimbursement, and ensuring comprehensive physician training.
The TAILORED-AF trial demonstrated that AI-guided tailored ablation using Volta AF-Xplorer, in combination with pulmonary vein isolation (PVI), resulted in significantly improved outcomes for persistent AF patients compared to standard PVI alone. Traditional methods like cryoballoon or laser balloon ablation also exist, but Volta AF-Xplorer aims to enhance precision and consistency by providing objective, real-time insights beyond subjective human interpretation.
Volta Medical's AI algorithms are powered by machine and deep learning, trained on extensive databases of electrograms meticulously annotated by expert electrophysiologists. While the 'black box' nature of deep learning is a general concern, the company emphasizes continuous algorithm refinement and clinical validation, such as through the TAILORED-AF trial, to build and maintain clinical trust in its AI-driven insights.
Specific pricing details for Volta AF-Xplorer are not publicly disclosed in the available information and would typically be obtained directly from Volta Medical or its distributors. Reimbursement and insurance coverage for AI-guided ablation procedures are evolving areas within healthcare, and physicians should consult with their institutional procurement and billing departments for current information.
Volta AF-Xplorer is engineered for versatility and integrates seamlessly with most existing EP recording systems, 3D navigation systems, and mapping catheters. Volta Medical provides resources and aims for smooth integration into diverse clinical workflows, with comprehensive physician training being crucial for successful adoption and effective utilization of the AI-driven insights.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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