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VX1

VX1

Product catalog summary

Overview: The VX1 system is an AI-enhanced tool designed to assist in atrial fibrillation (AF) and atrial tachycardia (AT) mapping during ablation procedures. It identifies spatio-temporal dispersion areas that indicate arrhythmia drivers, compatible with most mapping catheters and EP recording systems.

Key Features:

AI-enhanced detection of dispersion areas.
Compatibility with various mapping and navigation systems.
Real-time analysis using machine learning algorithms trained on a large database of expert-annotated electrograms (EGMs).
Facilitates a fast learning curve and standardized outcomes across operators.

Clinical Evidence:

Ev-AIFib2 Study: A multicentric study demonstrating the feasibility of VX1 dispersion maps for persistent AF ablation, involving 85 patients across 8 centers.
Tailored-AF5 Trial: An international trial comparing VX1-guided ablation strategy to conventional anatomical ablation, involving 374 patients across 26 sites.

Outcomes:

High rates of acute termination and freedom from AF/AT after procedures.
Standardization of ablation outcomes across different centers.

Regulatory Information: The VX1 system is a Class IIa Medical Device, CE marked and FDA cleared, manufactured by Volta Medical.

Company Information: Volta Medical is focused on AI solutions for electrophysiology, aiming to improve the diagnosis of complex heart rhythm diseases.

Catalog excerpts

VOLTA MEDICAL ARTIFICIAL INTELLIGENCE SOFTWARE FOR CARDIAC ELECTROPHYSIOLOGY Designed to facilitate AF & AT mapping during ablation procedures1. VXi provides an AI enhanced detection of spatio-temporal dispersion areas, indicative of drivers of the arrhythmia1,2,3. 1 Dispersion Indicator 2 Mapping Catheter Schematic 3 Mapping Cycle Length 4 Reference Cycle Length 5 Volta Dispersion Tags Compatibility with most mapping catheters EP recording and 3D navigation systems TRANFORMING EP DATA INTO AI SOLUTIONS

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AI DECISION SUPPORT SYSTEM Dispersion areas tagging Dispersed areas indicated on VX1 Machine/ Deep learning algorithms RAPID ANALYSIS WHAT VX1 BRINGS Real time analysis algorithm1. DATA DRIVEN Implements machine learning algorithms including deep learning1. EXPERT PHYSICIAN DATABASE Algorithms trained on a very large database of EGMs, annotated by expert electrophysiologists1. Allows for a fast learning curve2,4 and standardized outcomes across operators2.

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VX1 CLINICAL EVIDENCE Ev-AIFib2 Ev-AIFib2 is a prospective, multicentric, non-randomized study conducted to determine the feasibility and relevance of constructing VX1 dispersion maps for the ablation of persistent AF and that the use of VX1 allows for a robust center-to-center standardization of ablation outcomes. 12-Month Follow-up persistent & long-standing persistent AF patients sites (1 primary center and 7 satellite centers) operators using the 3 major mapping systems. Acute termination After single procedure Freedom from AF/AT* After one or multiple procedures (average of 1.3 procedures/patient)...

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Volta Medical is a data inspired, AI solutions EP company whose mission is to aid in the diagnosis of complex heart rhythm disease VX1TM SYSTEM USER MANUAL, I001-1.4-EU, February 2023. 2 SEITZ, Julien, MOHR DURDEZ, Théophile, ALBENQUE, Jean‐Paul, et 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 3 SEITZ, Julien, BARS, Clément, THÉODORE, Guillaume, et al. AF ablation guided by spatiotemporal electrogram dispersion without pulmonary vein...

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