Legal Mentions and References
ABOUT
The Volta AF-XplorerTM system is a class IIa Medical Device manufactured by Volta Medical. This product is CE marked by TÜV Rheinland LGA Products GmbH (0197) and FDA cleared.
INDICATIONS, SAFETY & WARNINGS
CAUTION: See User Manual/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-XplorerTM. There are no known potential adverse events associated with the use of Volta AF-XplorerTM.
Indications: Volta AF-XplorerTM is intended to assist 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-XplorerTM 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-XplorerTM has no specific contraindications.
All pictures shown are for illustration purpose only.
‡ Indicates a third party trademark, which is property of its respective owner.
1 VOLTA AF-XPLORERTM SYSTEM USER MANUAL, I110-2.1, July 2023
2 SEITZ, Julien, MOHR DURDEZ, Théophile, ALBENQUE, Jean‐Paul, and al. Artificial Intelligence Software Standardizes Electrogram‐based Ablation Outcome for Persistent Atrial Fibrillation. Journal of Cardiovascular Electrophysiology, 2022. https://doi.org/10.1111/jce.15657
3 SEITZ, Julien, BARS, Clément, THÉODORE, Guillaume, and al. AF ablation guided by spatiotemporal electrogram dispersion without pulmonary vein isolation: a wholly patient-tailored approach. Journal of the American College of Cardiology, 2017, vol. 69, no 3, p. 303-321. https://doi.org/10.1016/j.jacc.2016.10.065
4 DEISENHOFER, Isabel. Electrogram‐based AF ablation–finally, reproducibility! Journal of Cardiovascular Electrophysiology, 2022. https://doi.org/10.1111/jce.15660
