Abbott 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.
Approximately 12 million people in the United States over the age of 65 have AFib, a number expected to double over the next 20 years. 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 States. 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.
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 fibrillation (PAF) - episodes that come and go - as well as persistent AFib (PersAF) - episodes that last longer than seven days.
"AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life. When I perform a cardiac ablation, I look for a tool with an excellent patient safety profile that can simplify the treatment of AFib," said DJ Lakkireddy, M.D., executive medical director of the Kansas City Heart Rhythm Institute and one of the first physicians to use Volt in the United States. "Volt is a promising option for patients. Its real-time contact visualization and unique balloon-in-basket design provide superior tissue contact and focused energy delivery, while addressing some of the limitations of the early generation PFA systems."
