VX1+
Volta MedicalThe VX1+ by Volta Medical is an advanced cardiac mapping system that uses machine learning to assist clinicians by automatically or manually annotating 3D anatomical and electrical maps of the heart's atria. It helps identify areas exhibiting complex electrical activity during arrhythmias such as atrial fibrillation, potentially aiding catheter ablation procedures.
Intended Use
The VX1+ assists 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.
Technology
The VX1+ is a software algorithm running on a computing platform that receives analog or digital intra-cardiac signals from electrophysiology recording systems or a 3D mapping system. It performs real-time analysis using machine learning and signal processing to detect dispersed electrograms and annotate them manually or automatically on 3D anatomical maps. It supports bidirectional digital communication allowing automatic tagging with the EnSite X 3D mapping system.
Performance
Non-clinical testing included electromagnetic compatibility, electrical safety, thorough software verification and validation including algorithm module testing, and a reader study validating correlation with expert visual analysis. Usability evaluation in simulated and clinical environments confirmed no safety issues. Clinical testing involved a study with 22 patients confirming reliable detection and auto-tagging of dispersed electrograms without added risk or procedure time.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/22/2022
2 months - 2
FDA Approval
1/21/2023
Other devices from Volta Medical
- Volta AF-Xplorer2023 • 510K
- VX12020 • 510K
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