Volta AF-Xplorer
Volta MedicalThe Volta AF-Xplorer is a medical device that uses machine and deep learning algorithms to help clinicians annotate 3D anatomical and electrical maps of the human heart in real-time. It primarily assists in identifying regions within the atria that exhibit abnormal electrical activity during atrial fibrillation or atrial tachycardia, which can guide targeted catheter ablation procedures, improving patient outcomes.
Intended Use
The Volta AF-Xplorer 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 device consists of a computing platform and proprietary software that processes intra-cardiac multipolar signals using machine and deep learning techniques. It interfaces with existing electrophysiology recording and 3D mapping systems via analog or digital communication to analyze electrical maps in real-time and provides color-coded graphical feedback on dispersion areas, with automatic tagging functionality in certain configurations.
Performance
Performance validation includes results from the Tailored-AF clinical trial, demonstrating superiority of the device-assisted tailored ablation procedure for treating persistent atrial fibrillation compared to pulmonary vein isolation alone. The trial showed improved freedom from AF at 12 months with statistically significant results, along with safety data indicating comparable rates of major adverse events to standard procedures.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/11/2024
4 months - 2
FDA Approval
5/9/2025
Other devices from Volta Medical
- Volta AF-Xplorer2023 • 510K
- VX1+2023 • 510K
- VX12020 • 510K
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