Volta Medical Secures U.S. Label Expansion for Volta AF-Xplorer Artificial Intelligence (AI) decision support system, clinically proven to help physicians treat underserved patients with persistent atrial fibrillation.
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, announced a significant update to the U.S. labeling 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.
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TAILORED-AF is a prospective, multicenter, randomized 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.
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“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.”
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Source – PR Newswire
