Health
Abbott's Volt™ Pulsed Field Ablation System Receives FDA Approval to Treat Patients with Atrial Fibrillation
Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved the company's Volt™ PFA System to treat patients battling atrial fibrillation (AFib). 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.
About this update from Abbott Laboratories
[{"type":"list","items":[{"val":[{"type":"text","content":"Abbott's Volt™ PFA System, the latest generation of cardiac ablation technology, is designed for people battling heart rhythm disorders such as atrial fibrillation (AFib)","length":174,"tagName":"p"}]},{"val":[{"type":"text","content":"Pulsed field ablation – or PFA – is a minimally invasive procedure that uses high-energy electrical pulses in targeted areas of the heart to treat irregular heart rhythms","length":170,"tagName":"p"}]},{"val":[{"type":"text","content":"Abbott's Volt PFA System is an all-in-one product that is clinically proven to simplify the treatment of AFib that is gentler on the heart, has shorter procedure times and supports better recovery and long-term results","length":222,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":566,"olType":false},{"type":"text","content":"ABBOTT PARK, Ill., Dec. 22, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved the company's Volt™ PFA System to treat patients battling atrial fibrillation (AFib). 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.","length":409,"tagName":"p"},{"type":"text","content":"Approximately 12 million people in the United States over the age of 65 have AFib, a number expected to double over the next 20 years1. People living with AFib face a fivefold increased risk of stroke, and the condition has been a contributing cause of death for more than two decades in the United States2. When medication and other treatment options fail to work, many patients rely on a minimally invasive cardiac ablation procedure to effectively treat the condition by stopping irregular heart rhythms.","length":507,"tagName":"p"},{"type":"text","content":"Volt Demonstrates Strong Patient Outcomes for Abnormal Heart Rhythms FDA approval for the Volt PFA System was secured based on strong results from Abbott's VOLT-AF IDE study, a clinical trial of 392 patients conducted at 40 centers in the United States, Europe, Canada and Australia. The data showed that the Volt PFA System demonstrated clinically meaningful performance in both safety and effectiveness in two different patient groups: people battling paroxysmal atrial fib...