The VX1 is a cardiac mapping software tool designed to assist clinicians during atrial fibrillation or atrial tachycardia procedures by analyzing 3D anatomical and electrical maps of the heart's atria. Using machine and deep learning algorithms, it identifies complex dispersed electrograms in real-time to help guide electrophysiologists in annotating areas of interest, potentially improving mapping accuracy during catheter ablation procedures.
Intended Use
The VX1 assists 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.
Technology
The VX1 software uses machine and deep learning algorithms trained on a large database of annotated intra-cardiac atrial electrograms to detect dispersed electrograms in real-time during invasive cardiac mapping procedures. It works with existing acquisition systems and compatible catheters, using an analog-to-digital converter to process signals, and displays visual real-time cues to assist clinicians.
Performance
The VX1 device underwent rigorous non-clinical and clinical validation including inter-operator agreement studies, algorithm performance testing with over 275,000 annotated electrograms, k-fold cross-validation showing over 89% accuracy, and a multi-center clinical study on 300 patients demonstrating comparable efficacy to predicate devices without added risk or procedure time.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/15/2020
4 months - 2
FDA Approval
9/16/2020
Other devices from Volta Medical
- Volta AF-Xplorer2023 • 510K
- VX1+2023 • 510K
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