Volta Medical announced a labelling update for its Volta AF-Xplorer decision support system following the publication of landmark clinical data showing the system’s efficacy in treating persistent atrial fibrillation.
The Marseille, France-based company said that the new labelling incorporates data from the TAILORED-AF trial, a prospective, multicenter, randomized study that demonstrated the AI-assisted approach improved long-term outcomes compared to standard ablation methods. Results showed that 88% of patients treated with the AF-Xplorer-guided strategy were free from AFib at 12 months, compared to 70% in the control group.
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“This label expansion is an important step for Volta Medical, and for millions of patients living with persistent AF,” CEO and Co-founder Theophile Mohr Durdez said in a news release. “Clinical evidence now supports that Volta AF-Xplorer can assist physicians in improving outcomes for a vast and challenging arrhythmia population.”
Persistent AFib accounts for roughly 75% of all AFib patients but makes up only a third of catheter ablations, according to Volta. The Volta AF-Xplorer is the first system in electrophysiology to show level-one evidence of improved outcomes in this group, the company said.
The system uses AI to analyse real-time electrograms and help electrophysiologists identify specific types of abnormal electrical activity. Volta said the technology is compatible with leading mapping and ablation platforms and supports personalized treatment plans based on patient-specific signals.
