VX1+
Overview
The VX1+ is a machine and deep learning-based algorithm designed to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, also known as dispersed electrograms (DEs). This AI companion technology is designed for the assessment of complex Atrial Fibrillation (AF) and Atrial Tachycardia (AT) during ablation procedures. It helps physicians locate heart regions harboring specific electrogram abnormalities, potentially guiding intervention with radiofrequency or cryotherapy. The system is a non-sterile reusable medical device, composed of a computing platform and a software application, compatible with existing 510(k)-cleared catheters and specific data acquisition systems. It is an evolution of the earlier VX1 system and has been succeeded by the Volta AF-Xplorer II.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart
- Identification of spatio-temporal dispersed electrograms (DEs) during AF and AT procedures
- AI-driven insights to assist electrophysiologists during ablation procedures
- Compatibility with existing 510(k)-cleared catheters and specific data acquisition systems (e.g., Boston Scientific LabSystem Pro, GE HealthCare MacLab CardioLab EP Recording System, Abbott EnSite X 3D mapping system)
- Non-sterile reusable medical device
- Simple user interface with color coding for electrogram dispersion (blue, orange, red)
- Booster mode for increased sensitivity during AT or slow AF
- Provides cycle length estimation from electrograms
Use Cases
- Assisting electrophysiologists during catheter ablation procedures for atrial fibrillation (AF)
- Guiding treatment of complex cardiac arrhythmias
- Identifying electrical foci (root cause of fibrillation) during heart surgeries
- Improving outcomes for patients with persistent AF
- Streamlining workflow in electrophysiology labs
What Physicians Need to Know
VX1+ serves as an AI-powered decision support tool for electrophysiologists during atrial fibrillation and atrial tachycardia ablation procedures. It standardizes the identification of dispersed electrograms, which can be challenging to assess visually, potentially reducing operator variability. While initial studies show promising outcomes in terms of AF termination and freedom from arrhythmia, clinicians should note that the definitive clinical significance for improving ablation outcomes is still being evaluated in ongoing randomized controlled trials (e.g., TAILORED-AF). It is an assistive technology designed to enhance, not replace, expert clinical judgment.
VX1+ is engineered for broad compatibility within the electrophysiology lab, integrating with most readily available multipolar catheters and EP recording systems. It supports both unidirectional analog communication for manual annotation and advanced bidirectional digital communication with specific 3D navigation/mapping systems (such as Ensite X), enabling automated tagging of identified regions of interest for a more streamlined workflow.
Details
| Category | Cardiology AI, Surgical AI |
| Pricing | Not publicly available — N/A |
| Deployment | Software application on a computing platform, integrates with existing EP recording and 3D mapping systems. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The VX1+ device (K223516) received FDA clearance on January 21, 2023, as a machine and deep learning-based algorithm to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of dispersed electrograms. The FDA clearance states that the clinical significance of utilizing the VX1+ software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology |
What the Web Says
Volta Medical's VX1+ is an AI-powered software designed to assist electrophysiologists in real-time identification of abnormal electrograms (EGMs) during atrial fibrillation (AF) and atrial tachycardia (AT) ablation procedures. It aims to standardize the detection of these abnormal EGMs, which are associated with the perpetuation of AF, and potentially improve patient outcomes by guiding more accurate ablation. The device has received FDA clearance and CE mark.
Overall: PositiveStrengths
- Assists physicians in real-time identification of abnormal electrograms, improving accuracy of ablation procedures.
- Reproduces expert-physician EGM analysis, leading to standardization and reproducibility across different operators and centers.
- Demonstrated high freedom from atrial fibrillation and any atrial arrhythmia in patients after one-year follow-up (89% and 73% respectively, after an average of 1.3 procedures).
- Compatible with most readily available multipolar catheters and mapping technologies, eliminating the need for physicians to change their routine products.
- Potential to improve patient outcomes by providing more accurate treatment protocols for AF.
- May lead to increased efficiency and productivity for hospitals by allowing more procedures in a shorter time.
Limitations
- The clinical significance of utilizing VX1+ software to identify areas with spatiotemporal dispersion for catheter ablation of atrial arrhythmias has not been fully established by clinical investigations.
- No specific reviews from healthcare IT, tech reviewers, Reddit, G2, or Capterra were found for VX1+, though general alternatives to Volta Medical were listed on G2.
Based on reviews from: BioSpace, Medium, accessdata.fda.gov, BioWorld, Cardiac Rhythm News, Gilde Healthcare, Volta Medical
Last updated: 2026-07-22
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Press & Coverage
Videos
Product demos, reviews, and walkthroughs for VX1+.
AI-guided Long-standing persistent AF ablation
Julien Seitz
Volta AF-Xplorer: AI-Guided Ablation for Atrial Fibrillation | AI in Medicine Journal Club
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AI Support Improves Mapping in Atrial Fibrillation Ablation
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Frequently Asked Questions
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