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The TAILORED-AF randomized controlled trial demonstrated that AI-guided cardiac ablation using the Volta AF-Xplorer in combination with pulmonary vein isolation was superior to conventional anatomical PVI alone in achieving freedom from persistent atrial fibrillation at one year. The solution has received both U.S. FDA clearance and European CE Mark approval, supporting its use in clinical practice. Early commercialization efforts are underway alongside continued clinical validation through the RESTART trial targeting recurrent-AF patients who have failed prior ablations.
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