Volta Medical Gains U.S. Label Expansion for AI-Guided Cardiac Ablation

Volta Medical, a company aiming to treat complex atrial fibrillation (AFib) using artificial intelligence (AI) solutions, announced updated U.S. labeling for its flagship Volta AF-Xplorer system.

AF-Xplorer generates real-time, AI-driven insights that electrophysiologists can use for more patient-specific decision-making in catheter ablation procedures to treat AFib. The new labeling will include data from the company’s TAILORED-AF trial, which demonstrated significantly improved outcomes in treating persistent AFib compared to standard-of-care, the company said.

Specifically, the trial compared the Volta AF-Xplorer AI-guided tailored ablation to the standard of care. In the mITT population, 88% of patients in the tailored arm were AFib-free at 12 months, compared to 70% treated with standard pulmonary vein isolation.

According to Volta, the AF-Xplorer is the first system in electrophysiology’s history to show level one evidence of improved efficacy outcomes for patients with persistent AFib.

“This label expansion is an important step for Volta Medical, and for millions of patients living with persistent AF,” said Theophile Mohr Durdez, co-founder and CEO of Volta Medical. “Clinical evidence now supports that Volta AF-Xplorer can assist physicians in improving outcomes for a vast and challenging arrhythmia population.”

Last July, the company began a joint development agreement with GE HealthCare. The collaboration entails Volta integrating its AF-Xplorer with GE HealthCare’s Prucka 3 and CardioLab electrophysiology recording system. The combined technologies aim to boost performance and streamline workflows for electrophysiologists during catheter ablation to treat AFib.