Abbott Laboratories (NYSE:ABT) is included among the 14 Best Pharma Dividend Stocks to Buy in 2026. Abbott (ABT) Wins FDA Approval for Volt PFA System in AFib Treatment Courtesy of Abbott Labs On December 22, Abbott Laboratories (NYSE:ABT) said the US Food and Drug Administration has approved the company’s Volt™ PFA System to treat patients with atrial fibrillation, or AFib. The company plans to begin commercial PFA cases in the United States soon and will continue expanding sites across the European Un ...

Abbott Laboratories (ABT), the global healthcare titan, announced on Dec. 22 that the U.S. Food and Drug Administration (FDA) has approved its Volt™ PFA System for treating atrial fibrillation (AFib). Abbott will soon begin commercial PFA procedures in the U.S. and continue expanding European sites, building on Volt’s CE Mark approval earlier this year and accelerating global market penetration. AFib presents a rapidly growing clinical and economic burden. Around 12 million Americans aged over 65 current ...

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 Voltâ"¢ 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. 12 Minimal number of therapy applications and enhanced patient outcomes. The Volt PFA System is designed ...

Core Insights - Abbott has announced strong safety and efficacy data from its Volt CE Mark Study for the Volt™ PFA System, demonstrating positive results for patients with atrial fibrillation (AFib) over a 12-month period [1][6] Group 1: Study Findings - The Volt CE Mark Study showed that the Volt PFA System achieved an average of 4.7 therapy applications per vein, which is fewer than competitive PFA systems [1] - After 12 months, 83.5% of patients with paroxysmal atrial fibrillation (PAF) and 58.1% of patients with persistent AFib (PersAF) remained free from atrial arrhythmia, indicating one of the lowest recurrence rates in long-term PFA studies [7] - Quality of life (QoL) scores improved significantly from 64.1 to 88.1 after 12 months of treatment [7] Group 2: Safety Profile - The Volt PFA System demonstrated an excellent safety profile, with only 2.7% of patients experiencing a primary safety endpoint event, and no cases of hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury reported [7] - The study confirmed that the Volt PFA System can effectively treat both PAF and PersAF patients, enhancing procedural flexibility with options for light sedation or general anesthesia [4][8] Group 3: Study Design - The Volt CE Mark Study is a prospective, single-arm, non-randomized, multicenter study that enrolled 150 patients across 11 sites in Europe, focusing on symptomatic, recurrent, drug-refractory PAF and PersAF [8]

Core Insights - Abbott has received CE Mark approval for the Volt™ PFA System, enabling the treatment of atrial fibrillation (AFib) in Europe, with commercial cases already initiated [1][3] - The Volt PFA System is designed to improve the workflow of cardiac ablation procedures by utilizing a single-catheter approach, which allows for mapping, pacing, and ablating simultaneously [2][8] - The Volt PFA System demonstrated a 99.1% success rate in achieving pulmonary vein isolation (PVI) during clinical trials, outperforming existing competitive systems [3][10] Company Developments - Abbott has begun commercial use of the Volt PFA System in the EU, with plans for further expansion in the second half of the year [1] - Initial cases were performed by leading physicians in various European hospitals, indicating strong clinical interest and early adoption [3][4] - The Volt PFA System is part of Abbott's broader electrophysiology portfolio, which includes ongoing clinical studies and regulatory approvals for related technologies [11][12] Market Context - Approximately 8 million Europeans over 65 are currently living with AFib, a number projected to double in the next 30 years, highlighting a significant market opportunity for effective treatment solutions [2] - The Volt PFA System addresses limitations of existing PFA systems by providing enhanced visualization and navigation capabilities, which can lead to improved patient outcomes [6][10] - The integration of the Volt PFA System with Abbott's EnSite™ X EP system enhances procedural efficiency and accuracy, positioning Abbott favorably in the competitive landscape of electrophysiology [6][9]