Abbott’s Volt PFA system delivers strong 12-month AFib outcomes, heart rhythm society 2025 data reveal

Abbott (NYSE: ABT) has unveiled compelling new long-term clinical results for its Volt™ Pulsed Field Ablation (PFA) System, showcasing durable safety and efficacy out to 12 months for patients treated for atrial fibrillation (AFib). Presented during the 2025 Heart Rhythm Society (HRS) annual meeting in San Diego, the data from Abbott’s Volt CE Mark Study further reinforce the Volt system’s strong performance, minimal risk profile, and significant quality of life improvements for patients battling both paroxysmal and persistent forms of AFib.

The latest findings, also published in the Heart Rhythm journal, mark an important milestone for the future of cardiac ablation therapy. Notably, the Volt PFA System achieved these outcomes with an average of just 4.7 therapy applications per vein — a more efficient approach compared to existing pulsed field ablation technologies.

What Makes Abbott’s Volt PFA System Stand Out in AFib Treatment?

The Volt PFA System represents a next-generation advancement in AFib care by delivering high-energy, precisely targeted electrical pulses to modify cardiac tissue responsible for arrhythmias. Unlike traditional thermal-based ablation methods, pulsed field ablation aims to minimize collateral damage, a benefit that was clearly reflected in Abbott’s latest data.

The Volt CE Mark Study included patients suffering from paroxysmal atrial fibrillation (PAF), characterized by intermittent episodes, and persistent atrial fibrillation (PersAF), defined by episodes lasting more than seven days. According to Abbott, these groups traditionally present unique challenges in treatment outcomes, making the Volt system’s consistent performance across both segments particularly notable.

Professor Gian-Battista Chierchia of the Heart Rhythm Management Institute at the University of Brussels observed that the Volt system delivered exceptional results across patient types, suggesting that the technology can adapt effectively to differing clinical scenarios.

How Did Patients Fare After 12 Months with the Volt PFA System?

At the one-year mark, the Volt CE Mark Study showed that 83.5% of patients with paroxysmal AFib remained free from arrhythmias, one of the most impressive figures reported in long-term pulsed field ablation studies to date. Among patients with persistent AFib, 58.1% remained arrhythmia-free, affirming Volt’s effectiveness even in harder-to-treat cases.

The study also captured significant improvements in patients’ quality of life scores, which rose from 64.1 to 88.1 over the year-long period. Importantly, only 2.7% of participants experienced primary safety endpoint events, with no incidents of hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve damage — all recognized risks associated with ablation procedures.

These results, according to Abbott’s Chief Medical Officer for electrophysiology, Dr. Christopher Piorkowski, highlight how the Volt PFA System was deliberately engineered to deliver broad therapeutic benefits while minimizing procedural risks.

Does Sedation Type Impact Volt PFA System Outcomes?

A key sub-analysis presented at the 2025 Heart Rhythm Society meeting offered another critical insight: the type of sedation used during the Volt PFA procedure — whether conscious, deep, or general anesthesia — did not significantly affect safety or acute effectiveness outcomes. This procedural flexibility, Abbott noted, could make Volt particularly advantageous in clinical environments with varying anesthesia capabilities.

The Volt PFA System’s ability to operate effectively under light sedation without compromising outcomes is likely to enhance its adoption across different care settings, offering hospitals greater workflow efficiency and cost-effectiveness.

What Are the Broader Implications for Pulsed Field Ablation Therapy?

Abbott’s Volt CE Mark Study is a pivotal demonstration of pulsed field ablation’s long-term potential in reshaping AFib treatment standards. The study enrolled 150 patients across 11 sites in Europe and incorporated a feasibility sub-study using advanced imaging modalities to verify the acute safety of the system. This comprehensive evaluation adds substantial credibility to the Volt system’s safety claims.

Given that the Volt PFA System operates with a single-catheter solution, further simplifying procedures, the system could represent a significant leap forward in making ablation therapy more accessible, less invasive, and faster for a wider range of AFib patients globally.

Clinical adoption post-CE Mark approval has reportedly supported the Volt system’s strong performance, with real-world experience echoing the outcomes observed in controlled study environments.

How Is Abbott Positioning Itself for the Future of Electrophysiology?

With a diverse healthcare portfolio spanning diagnostics, medical devices, nutritionals, and branded generics, Abbott continues to strengthen its position as a global leader in transformative healthcare technologies. Employing over 114,000 people and serving over 160 countries, Abbott’s strategic focus on expanding in fast-growing therapeutic areas such as electrophysiology places the company in a commanding position for long-term growth.

The Volt PFA System’s robust 12-month data bolster Abbott’s ambitions to set a new standard in AFib care, leveraging innovation to deliver improved patient outcomes while addressing procedural complexity.

How Is Abbott’s Stock Responding?

Following the announcement of the Volt PFA System’s 12-month study results, sentiment around Abbott stock (NYSE: ABT) remained largely positive. Analysts viewed the strong data as validation of Abbott’s continued innovation strength within the cardiovascular segment. While overall healthcare stocks faced broader market pressure in April 2025 due to macroeconomic concerns, investor sentiment specific to Abbott’s electrophysiology advancements remains bullish.

Institutional flows into healthcare ETFs that include Abbott holdings saw modest upticks after the Heart Rhythm Society conference presentations, suggesting growing institutional confidence in Abbott’s future pipeline strength.

What Does the Future Hold for PFA Therapy with Abbott Volt?

The long-term results from Abbott’s Volt CE Mark Study not only validate the Volt PFA System’s safety and efficacy but also reinforce pulsed field ablation’s broader promise in transforming arrhythmia management. With consistent outcomes across patient types, improved procedural flexibility, and significant quality of life enhancements, Abbott is poised to lead a pivotal shift in how atrial fibrillation is treated worldwide.