Volta Clinical Evidence Roadmap

The Volta Clinical Evidence Roadmap

One of the most ambitious clinical programs focused on the underserved complex Atrial Fibrillation (AF) patient

The Problem

Underserved population of Complex AFib Patients

70%

of all AFib patients suffer from complex AF¹

<50%

of catheter ablation treatments are persistent AF patients²

Our Approach

Industry-Leading Research Scope and quality

Legal Mentions and References

ABOUT
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The Volta AF-Xplorer™ system is a Medical Device manufactured by Volta Medical. This product is FDA cleared.

INDICATIONS, SAFETY & WARNINGS

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See 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 Volta AF-Xplorer application. There are no known potential adverse events associated with the use of Volta AF-Xplorer.

Indications: 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.

The clinical significance of utilizing the Volta AF-Xplorer 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 Volta AF-Xplorer has no specific contraindications.
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All pictures shown are for illustration purpose only.
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^‡ Indicates a third party trademark, which is property of its respective owner.