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
AF Ablation Guided by Spatiotemporal Electrogram Dispersion Whithout Pulmonary Vein Isolation
Ev-AIFib
Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation
Clinical Registry
Multicenter Prospective Study
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.
