Legal Mentions and References
ABOUT
The VX1 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 VX1 application. There are no known potential adverse events associated with the use of VX1.
Indications: VX1 is intended to assist 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.
The clinical significance of utilizing the VX1 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 VX1 has no specific contraindications.
All pictures shown are for illustration purpose only.
1 VX1 SYSTEM USER MANUAL, I001-1.4, February 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
