Next-generation electrical pulse therapy Abbott has officially received approval from the U.S. Food and Drug Administration (FDA) for its Volt™ Pulsed Field Ablation (PFA) System, an advanced solution for treating atrial fibrillation—a widespread heart rhythm disorder. Unlike traditional thermal methods, the Volt™ system utilizes targeted high-energy electrical pulses to block erratic electrical signals in the heart. The system’s unique design enhances tissue contact, optimizing energy transfer and reducing the number of therapy applications required during a procedure.
Insights from multi-national clinical trials The FDA’s decision was supported by data from the VOLT-AF IDE clinical study, which involved 392 patients across 40 centers in the United States, Europe, Canada, and Australia. The trial demonstrated significant safety and effectiveness for both paroxysmal atrial fibrillation (intermittent episodes) and persistent atrial fibrillation (longer-lasting episodes). Integrated with the EnSite™ X 3D mapping technology, the system allows for precise targeting, fewer catheter exchanges, and significantly shorter procedural times.
Patient benefits and operational efficiency The Volt™ system offers the option for procedures to be conducted under conscious sedation rather than general anesthesia, leading to faster recovery and lower risks. Additionally, the technology helps minimize radiation exposure and reduces the breakdown of red blood cells during treatment. The commercial launch of this system in the U.S., following its earlier launch in the European Union, reinforces Abbott’s leadership in cardiovascular care by providing a safer, minimally invasive option for millions of patients.