Volta Medical has announced a “significant update” to the US labelling of its flagship system, Volta AF-Xplorer. Labelling will now include “groundbreaking” clinical data from the TAILORED-AF trial, which showed significantly improved long-term outcomes compared to standard-of-care treatment for persistent atrial fibrillation (AF), according to a Volta press release.
“This label expansion is an important step for Volta Medical, and for millions of patients living with persistent AF,” said Theophile Mohr Durdez, Volta’s chief executive officer (CEO) and co-founder. “Clinical evidence now supports that Volta AF-Xplorer can assist physicians in improving outcomes for a vast and challenging arrhythmia population.”
The Volta AF-Xplorer system is designed to deliver real-time, artificial intelligence (AI)-driven insights to electrophysiologists in order to enable more patient-specific decision-making in catheter ablation procedures for AF. Volta’s recent release notes that persistent AF is among the most challenging cardiac arrhythmias and represents the majority of all patients suffering from AF—yet only one third of catheter ablations are performed on this more progressed disease state, resigning many to living with the debilitating condition.
Published earlier this year in Nature Medicine, TAILORED-AF is a prospective, multicentre randomised controlled trial comparing the standard of care in persistent AF to AI-guided, tailored Volta AF-Xplorer ablation. Based on the trial’s modified intention-to-treat (mITT) population, “compelling” results include 88% of patients in the tailored treatment arm being free from AF at 12 months versus 70% of patients treated with standard pulmonary vein isolation (PVI; p<0.0001).
“The Volta AF-Xplorer is the first system in the history of electrophysiology to demonstrate level-one evidence of improved efficacy outcomes for persistent AF patients,” Volta claims in its recent release.
