Volta VX1

VX1 brings the acute and long-term outcomes of expert electrophysiologists inside the EP lab,¹ by automatically detecting dispersed electrograms, indicative of arrhythmia’s drivers.³

RAPID ANALYSIS

Guides real-time decision-making with machine learning algorithms including deep learning algorithms.¹

DATA DRIVEN

Algorithms trained on a very large database of EGMs, annotated by expert electrophysiologists.¹

INTERFACE

Simple User Interface for Real-Time Regions of Interest Identification.

1. DISPERSION LOCATION: Multipolar electrogram abnormality associated with the perpetuation of atrial fibrillation.
Red: highly dispersed electrograms.
Orange: dispersed electrograms.
Blue: non-dispersed electrograms.¹

2. MAPPING CATHETER: Steerable, multipolar electrode catheter. Allows for the recording of the heart’s local electrical activity.^1
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3. BOOSTER MODE: May be activated during AT or slow AF to increase software sensitivity.¹

4. REFERENCE CYCLE LENGTH: Atrial cycle length estimated from real-time recordings obtained with the coronary sinus catheter.¹

5. MAPPING CYCLE LENGTH: Local cycle length estimated from real-time recordings obtained with the mapping catheter.¹

Legal Mentions and References

ABOUT
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The VX1 system is a class IIa Medical Device manufactured by Volta Medical. This product is CE marked by TÜV Rheinland LGA Products GmbH (0197) and FDA cleared.

INDICATIONS, SAFETY & WARNINGS

CAUTION: See User Manual/Instructions for Use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. All safety considerations, cautions and warnings that apply to the general use of a medical system in an operating room, also apply while using VX1 application. There are no known potential adverse events associated with the use of VX1.

Indications: VX1 is intended to assist operators in the real-time manual 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.

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.

Contraindications: The VX1 has no specific contraindications.

All pictures shown are for illustration purpose only.
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¹VX1 SYSTEM USER MANUAL, I001-1.4, February 2023
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²SEITZ, Julien, MOHR DURDEZ, Théophile, ALBENQUE, Jean‐Paul, and al. Artificial Intelligence Software Standardizes Electrogram‐based Ablation Outcome for Persistent Atrial Fibrillation. Journal of Cardiovascular Electrophysiology, 2022. https://doi.org/10.1111/jce.15657
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³SEITZ, Julien, BARS, Clément, THÉODORE, Guillaume, and al. AF ablation guided by spatiotemporal electrogram dispersion without pulmonary vein isolation: a wholly patient-tailored approach. Journal of the American College of Cardiology, 2017, vol. 69, no 3, p. 303-321. https://doi.org/10.1016/j.jacc.2016.10.065
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⁴DEISENHOFER, Isabel. Electrogram‐based AF ablation–finally, reproducibility! Journal of Cardiovascular Electrophysiology, 2022. https://doi.org/10.1111/jce.15660

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RAPID ANALYSIS

DATA DRIVEN

COMPATIBILITY