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Dec 22, 2025 4:00 PM

FDA Clears Abbott's Volt PFA System For AFib, Expanding US Treatment Options

On Monday, the U.S. Food and Drug Administration (FDA) approved Abbott Laboratories’ (NYSE:ABT) Volt PFA System to treat patients battling atrial fibrillation (AFib).

AFib is the most common type of irregular heart rhythm (arrhythmia) where the heart’s upper chambers (atria) quiver rapidly and chaotically instead of beating effectively, leading to a fast, irregular pulse, palpitations, shortness of breath, and fatigue, and significantly increasing the risk of blood clots, stroke, and heart failure due to poor blood flow.

Abbott will soon begin commercial PFA cases in the United States and will continue its expansion of sites in the European Union following Volt CE Mark approval earlier this year.

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