New Clinical Study Data Showcase Long-Term, Sustained Benefits of Abbott's Volt™ PFA System for Patients with AFib

Rhea-AI Summary

Abbott (NYSE: ABT) has revealed compelling 12-month data from its Volt CE Mark Study, demonstrating sustained benefits of the Volt™ PFA System for treating atrial fibrillation. The study, presented at the 2025 Heart Rhythm Society meeting, showed impressive results for both paroxysmal (PAF) and persistent AFib patients.

Key findings after 12 months include:

• 83.5% of PAF patients and 58.1% of PersAF patients remained arrhythmia-free
• Quality of life scores improved significantly from 64.1 to 88.1
• Only 2.7% of patients experienced primary safety endpoint events
• Zero patients suffered from common PFA therapy complications
• System achieved results with just 4.7 applications per vein on average

The Volt PFA System utilizes high-energy electrical pulses for targeted cardiac tissue treatment and can be administered under either light sedation or general anesthesia, offering procedural flexibility.

Positive

• High success rate with 83.5% of PAF patients remaining arrhythmia-free at 12 months
• Significant improvement in quality of life scores from 64.1 to 88.1
• Excellent safety profile with only 2.7% primary safety endpoint events
• More efficient treatment with fewer applications per vein (4.7) compared to competitors
• Flexible sedation options without compromising effectiveness

Negative

• Lower success rate in persistent AFib patients (58.1%) compared to PAF patients (83.5%)

Insights

Cardiovascular Electrophysiology Specialist

Abbott's Volt PFA System shows exceptional 12-month efficacy with 83.5% arrhythmia-free PAF patients and strong safety profile, representing significant clinical advancement.

The 12-month data from Abbott's Volt CE Mark Study represents a significant clinical milestone in the electrophysiology landscape. The freedom from arrhythmia rates are particularly noteworthy - 83.5% for paroxysmal AFib patients is among the best outcomes in long-term PFA studies to date, while the 58.1% for persistent AFib patients demonstrates efficacy in a historically more challenging population.

What sets these results apart is the comprehensive safety profile. The 2.7% primary safety endpoint rate is impressively low, with zero cases of hemolysis, coronary spasm, pulmonary vein stenosis, kidney injury, or phrenic nerve injury - all recognized complications with PFA therapy. This suggests Abbott's technology has effectively addressed key safety concerns in the field.

The system's procedural efficiency (requiring just 4.7 applications per vein) represents a meaningful advantage over competing systems, potentially reducing procedure duration and minimizing unnecessary tissue exposure. Additionally, the substantial quality of life improvement (scores rising from 64.1 to 88.1) demonstrates the therapy's tangible impact on patient well-being beyond simply controlling arrhythmia.

The flexibility to perform procedures under various sedation levels without compromising outcomes (as shown in the VOLT-AF IDE sub-analysis) expands the utility across different clinical settings and patient populations. This versatility, combined with the consistent performance across both paroxysmal and persistent AFib, positions the Volt PFA System as a comprehensive solution for electrophysiologists treating the spectrum of atrial fibrillation.

Medical Technology Financial Analyst

Abbott's Volt PFA system demonstrates superior clinical outcomes across multiple AFib patient groups, strengthening its competitive position in the high-growth electrophysiology market.

These 12-month results from the Volt CE Mark Study significantly strengthen Abbott's position in the rapidly evolving pulsed field ablation market for AFib treatment. The dual efficacy across both paroxysmal and persistent AFib patients effectively expands the addressable market for the Volt system, as it demonstrates capability across the spectrum of AFib severity.

The system's demonstrated procedural efficiency (fewer therapy applications than competitors) creates a compelling competitive advantage that addresses both clinical outcomes and operational economics. The flexibility to use various sedation approaches without compromising results provides hospitals and electrophysiology labs with workflow options that could reduce resource requirements and potentially expand treatment settings.

Particularly impressive is the quality of life improvement data, with scores improving from 64.1 to 88.1 over 12 months. This patient-centered outcome provides Abbott with powerful marketing evidence beyond technical specifications when engaging with providers and payers.

The safety profile data (just 2.7% primary safety endpoint events and zero occurrences of several major complications) addresses a critical adoption barrier for new technologies in the cardiovascular space. With CE Mark approval already secured, these compelling long-term results provide Abbott with robust clinical evidence to support European commercialization efforts for the Volt PFA System.

The simultaneous publication in Heart Rhythm (the official journal of HRS) alongside the conference presentation enhances credibility and visibility of these results within the electrophysiology community, potentially accelerating adoption among key opinion leaders.

• Long-term data from the Volt CE Mark Study show strong results out to 12 months in patients receiving pulsed field ablation (PFA) therapy with the Volt™ PFA System
• The 12-month results of the Volt CE Mark Study confirm the long-term safety and efficacy of the Volt PFA System
• The data were presented at the 2025 Heart Rhythm Society (HRS) annual meeting

ABBOTT PARK, Ill., April 26, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) has announced new data from its Volt CE Mark Study that show strong safety and efficacy out to 12 months for patients receiving pulsed field ablation (PFA) therapy with the Volt™ PFA System for the treatment of atrial fibrillation (AFib). The data also highlights the excellent safety profile of the Volt PFA System alongside the system's ability to achieve results with fewer therapy applications (just 4.7 applications per vein on average) than on-market competitive PFA systems.

PFA therapy works differently from traditional cardiac ablation approaches by delivering high energy electrical pulses to targeted areas of cardiac tissue causing abnormal heart rhythms. Abbott designed its Volt CE Mark Study to assess the impact of the Volt PFA System 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.

The 12-month data from the Volt CE Mark Study were presented at the 2025 Heart Rhythm Society (HRS) annual meeting held in San Diego (April 24-27, 2025) and simultaneously published in Heart Rhythm, the official journal of the Heart Rhythm Society.

Sustained Performance of the Volt PFA System
Data from the Volt CE Mark Study showed that after 12 months, Abbott's Volt PFA System delivered:

• Outstanding long-term performance. The Volt PFA System demonstrated sustained performance in both safety and effectiveness out to 12 months for patients with PAF and PersAF.
• Freedom from arrhythmia. 83.5% of PAF patients and 58.1% of PersAF patients remained free from atrial arrhythmia after 12 months – one of the lowest rates of reoccurrence in PAF patients in a long-term PFA study to date.
• Quality of life (QoL) benefits. After 12 months, the Volt CE Mark Study showed a significant QoL benefit for patients, with QoL assessment scores improving from 64.1 to 88.1.
• Excellent safety profile. After 12 months, just 2.7% of Volt patients had experienced a primary safety endpoint event with zero patients suffering from hemolysis (destruction of red blood cells), coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury – all potential challenges of PFA therapy.

"The long-term 12-month results from the Volt CE Mark Study paint a picture of a PFA system that performs exceptionally well in two different groups of patients – each with unique therapy needs and clinical approaches," said Prof. Gian-Battista Chierchia, director of the Atrial Fibrillation Program at the Heart Rhythm Management Institute at the University of Brussels in Belgium. "These long-term data provide us a strong picture of how the Volt PFA System will perform in clinical settings as we leverage PFA therapy for our patients."

To date, clinical experience following CE Mark has further confirmed that the Volt PFA System can support treating patients battling either PAF or PersAF, allowing the system to help as many patients as possible. The Volt PFA System also provides a single-catheter PFA approach, improves workflow and provides procedural flexibility by allowing for light sedation or general anesthesia. A new sub-analysis from the VOLT-AF IDE Study presented at HRS 2025 showed no significant difference in safety or acute effectiveness outcomes in cases performed under conscious or deep sedation when compared to procedures performed with general anesthesia.

"Our goal from the beginning with the Volt PFA System was to design a PFA system that would provide outstanding results in patients battling a range of atrial arrhythmias, and the latest data from the Volt CE Mark Study is confirmation that the system will truly impact patient care in a positive way," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business.

About the Volt CE Mark Study
Abbott's Volt CE Mark Study is a prospective, single-arm, non-randomized, multicenter study designed to demonstrate the safety and effectiveness of the Volt PFA System for the treatment of symptomatic, recurrent, drug-refractory PAF and PersAF. The study enrolled 150 patients at 11 sites across Europe and included a feasibility sub-study in which additional imaging assessments were collected to confirm the acute safety of the Volt PFA System.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

 

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SOURCE Abbott

FAQ

What are the 12-month success rates for Abbott's Volt PFA System in treating AFib?

After 12 months, 83.5% of paroxysmal AFib patients and 58.1% of persistent AFib patients remained free from atrial arrhythmia.

How does Abbott's Volt PFA System improve patient quality of life?

The study showed quality of life assessment scores improved significantly from 64.1 to 88.1 over 12 months.

What is the safety profile of Abbott's Volt PFA System for AFib treatment?

Only 2.7% of patients experienced primary safety endpoint events, with zero cases of hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury.

How many applications per vein does Abbott's Volt PFA System require?

The Volt PFA System requires an average of 4.7 applications per vein, fewer than competitive PFA systems.

Can Abbott's Volt PFA System be used with different sedation options?

Yes, the system shows no significant difference in safety or effectiveness whether used under conscious sedation, deep sedation, or general anesthesia.