Legal Mentions and References
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.
All pictures shown are for illustration purpose only.
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