Volta Medical, a health technology company on a mission to treat the underserved complex atrial fibrillation (AF) patient population through the use of intelligent, AI solutions, has announced a significant update to the U.S. labelling of its flagship system, Volta AF-Xplorer. The AF-Xplorer delivers real-time, AI-driven insights to electrophysiologists, enabling more patient-specific decision-making in catheter ablation procedures treating AF.
Labeling will now include the groundbreaking clinical data from the landmark TAILORED-AF trial which showed significantly improved long-term outcomes in the treatment of persistent AF compared to standard-of-care. Persistent AF is among the most challenging cardiac arrhythmias and represents 3/4 of all patients suffering from AF. However, only 1/3 of catheter ablations are performed on this more progressed disease state, resigning many to live with the debilitating disease.
TAILORED-AF is a prospective, multicenter, randomised controlled trial comparing standard of care to the Volta AF-Xplorer AI-guided tailored ablation. Results are compelling: in the mITT population 88% of patients in the tailored arm were free from AF at 12 months, compared to just 70% of patients treated with standard pulmonary vein isolation (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. The study was published in Nature Medicine earlier this year.
“This label expansion is an important step for Volta Medical, and for millions of patients living with persistent AF,” said Theophile Mohr Durdez, CEO and co-founder of Volta Medical. “Clinical evidence now supports that Volta AF-Xplorer can assist physicians in improving outcomes for a vast and challenging arrhythmia population.”
