Late-breaking data presentations showcase the safety and efficacy of Abbott's ablation catheters to treat people with atrial fibrillation

Abbott (NYSE: ABT) reported late-breaking clinical results (Feb 6, 2026) showing strong safety and efficacy for two AFib ablation devices: the Volt™ Pulsed Field Ablation (PFA) System and the TactiFlex™ Duo Ablation Catheter, Sensor Enabled.

Rhea-AI Summary

Abbott (NYSE: ABT) reported late-breaking clinical results (Feb 6, 2026) showing strong safety and efficacy for two AFib ablation devices: the Volt™ Pulsed Field Ablation (PFA) System and the TactiFlex™ Duo Ablation Catheter, Sensor Enabled.

Key highlights: Volt showed 84.2% freedom from rhythm recurrence in PAF and ~68% in persistent AF at 12 months, 6% repeat ablation rate, and marked AFEQT QoL improvements. TactiFlex Duo showed 81% freedom from recurrence in PAF at six months and supported CE Mark approval.

Positive

• Volt PFA 12-month freedom from recurrence at 84.2% (PAF)
• Persistent AF freedom ~68% at 12 months with Volt
• Low repeat ablation rate under 6% for Volt
• Strong QoL gains AFEQT scores rose to 91.4 for Volt patients
• TactiFlex Duo 6-month success 81% freedom from recurrence (PAF)
• Regulatory progress Volt FDA approval and CE Mark; TactiFlex CE Mark

Negative

• TactiFlex in U.S. approved for investigational use only, limiting immediate U.S. commercial availability
• Lower durability for persistent AF Volt ~68% versus 84.2% in PAF at 12 months

Argus Feb 6 session

+1.60% close to close Open Argus

Details

News Market Reaction – ABT

In the Feb 6 session, ABT gained 1.60%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights robust 12-month and 6-month data for Abbott’s Volt PFA and TactiFlex Du...

Analysis

This announcement highlights robust 12-month and 6-month data for Abbott’s Volt PFA and TactiFlex Duo systems in atrial fibrillation, reinforcing earlier approvals and CE Marks referenced in prior news. Historical disclosures show Abbott steadily expanding its cardiovascular and diabetes technology portfolios. Investors may focus on how these results translate into procedure volumes, geographic uptake, and follow-on studies, while also tracking future regulatory milestones and product launches across the broader device pipeline.

Key Figures

Volt PFA PAF success: 84.2% Volt PFA PersAF success: 68% Therapy applications: 4.6 applications/vein +5 more

Volt PFA PAF success

84.2%

Freedom from documented rhythm recurrence at 12 months in VOLT-AF IDE

Volt PFA PersAF success

68%

Patients free from additional AFib episode after Volt ablation

Therapy applications

4.6 applications/vein

Average Volt therapy applications per vein vs other PFA systems

Repeat ablation rate

<6%

Patients requiring repeat ablation in VOLT-AF IDE through one year

QoL PAF Volt

63.6 to 91.4

AFEQT quality-of-life score change for PAF patients treated with Volt

QoL PersAF Volt

64.2 to 91.4

AFEQT quality-of-life score change for PersAF patients treated with Volt

TactiFlex PAF success

81%

Freedom from rhythm recurrence at 6 months in FOCALFLEX CE Mark trial

QoL TactiFlex PAF

64.4 to 86.4

Patient self-reported quality-of-life change with TactiFlex Duo

Historical Context

5 past events · Latest: Jan 22

5 events

1. Jan 22

   Earnings and guidance

   24h Move

   -10.0%

   Strong Q4 and 2025 results with solid 2026 outlook and M&A update.

2. Jan 20

   Device CE Mark

   24h Move

   -0.5%

   CE Mark for TactiFlex Duo enabling EU AFib treatment expansion.

3. Jan 05

   Earnings call notice

   24h Move

   +1.1%

   Announcement of timing and access details for Q4 2025 call.

4. Jan 05

   Product feature launch

   24h Move

   +1.8%

   Launch of Libre Assist AI feature for real-time food decision support.

5. Dec 22

   FDA device approval

   24h Move

   -0.2%

   FDA approval of Volt PFA System for atrial fibrillation treatment.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pulsed field ablation, atrial fibrillation, paroxysmal afib, persistent afib, +4 more

8 terms

pulsed field ablation medical

"reinforce the Volt™ Pulsed Field Ablation (PFA) System's industry-leading..."

Pulsed field ablation is a heart procedure that uses very short, high-voltage electrical pulses to selectively disrupt abnormal heart tissue that causes irregular rhythms, rather than heating or freezing it. For investors, it matters because this approach can shorten procedure times, reduce damage to nearby structures, and potentially lower complication rates compared with traditional thermal methods, which can affect device adoption, hospital costs, and market demand for treatment tools.

atrial fibrillation medical

"therapies to treat people with atrial fibrillation (AFib)."

Atrial fibrillation is a common heart rhythm problem in which the heart’s upper chambers quiver instead of delivering steady, strong pumps, like a washing machine on an unbalanced cycle. It matters to investors because it increases use of medications, medical devices, hospital care and long‑term monitoring, drives demand for new treatments and diagnostics, and can affect healthcare costs, regulatory decisions and revenue prospects across drug, device and insurance markets.

paroxysmal afib medical

"to treat AFib episodes that come and go (Paroxysmal AFib or PAF)."

Paroxysmal afib is a type of irregular heart rhythm that starts suddenly and stops on its own, often lasting minutes to a few days before returning to normal. For investors, it matters because its intermittent nature affects how patients use medications, devices and follow-up care, which in turn influences market size, treatment adoption patterns and the design and expected outcomes of clinical trials, much like unpredictable demand cycles affect sales in other industries.

persistent afib medical

"for AFib episodes that last longer than seven days (Persistent AFib or PersAF)"

Persistent atrial fibrillation is a heart rhythm disorder where the upper chambers of the heart beat irregularly and do not return to a normal rhythm on their own, lasting longer than a week or requiring medical treatment to stop. Think of it as a song stuck on the wrong track that needs intervention to fix; it matters to investors because it drives demand for drugs, medical devices, procedures and ongoing clinical trials, influences treatment costs and reimbursement, and can affect companies’ revenues and regulatory risk profiles.

ventricular tachycardia medical

"to treat Ventricular Tachycardia – a potentially life-threatening fast heart rate"

A fast, abnormal heartbeat that starts in the heart’s lower chambers and can sharply reduce blood flow, potentially causing dizziness, fainting or, in severe cases, sudden collapse; picture an engine running so fast it loses power. For investors, ventricular tachycardia matters because demand for drugs, devices, diagnostic tests and emergency care tied to this condition affects clinical trial results, regulatory approvals, revenue prospects and legal or safety risks for healthcare companies.

ce mark regulatory

"New data from the FOCALFLEX CE Mark trial demonstrate the safety and efficacy..."

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

fda approval regulatory

"The Volt PFA System secured U.S. Food and Drug Administration (FDA) approval..."

FDA approval is the U.S. Food and Drug Administration’s formal authorization for a drug, vaccine, or medical device to be marketed and sold after reviewers determine it meets standards for safety and effectiveness. For investors it’s a pivotal milestone because it opens the door to legal, large-scale sales and can sharply boost revenue potential while reducing regulatory uncertainty—like receiving a safety certificate that lets a new bridge carry traffic and tolls.

breakthrough device designation regulatory

"the FDA granted Breakthrough Device Designation for TactiFlex Duo to treat..."

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• Positive 12-month results from the VOLT-AF IDE Study presented at the AF Symposium and simultaneously published in JACC: Clinical Electrophysiology, reinforce the Volt™ Pulsed Field Ablation (PFA) System's industry-leading success rate for treating AFib¹
• New data from the FOCALFLEX CE Mark trial demonstrate the safety and efficacy of the TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, to significantly reduce AFib episodes for complex cases²

ABBOTT PARK, Ill., Feb. 6, 2026 /PRNewswire/ -- Abbott (NYSE: ABT) today announced new clinical data from two late-breaking presentations at AF Symposium in Boston (February 5-7, 2026) that demonstrate the strong safety and efficacy of the company's minimally invasive therapies to treat people with atrial fibrillation (AFib). The results include 12-month findings that reinforce the long-term safety and performance of Abbott's Volt™ Pulsed Field Ablation (PFA) System, which were simultaneously published in JACC: Clinical Electrophysiology. Positive results were also presented on Abbott's TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, a dual-energy, focal ablation catheter engineered to allow physicians to tailor how they deliver AFib therapy.

Sustained performance of the Volt PFA System
Twelve-month data from the VOLT-AF Global IDE study found that the Volt PFA System had an industry-leading success rate (84.2%) of freedom from documented rhythm recurrence among all competitive PFA products to treat AFib episodes that come and go (Paroxysmal AFib or PAF).¹

Volt also delivered strong results as a treatment option for AFib episodes that last longer than seven days (Persistent AFib or PersAF), with nearly 68% of patients remaining free from an additional episode following a Volt ablation.¹ 

Additional key findings of the single-arm trial conducted at approximately 40 centers in the United States, Europe, Canada and Australia through one year include: ¹

• Physicians were able to use fewer therapy applications (just 4.6 applications per vein on average) than other on-market competitive PFA systems.
• The trial found less than 6% of patients required a repeat ablation, one of the lowest rates in the industry.
• Patients reported a significant improvement in quality-of-life (QoL) as measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score. This self-assessment – which evaluates changes to a person's overall symptoms and social well-being – show scores rose from 63.6 to 91.4 for PAF patients treated with Volt and from 64.2 to 91.4 for PersAF patients. The study also found zero patient complications related to either an unintended injury to the esophagus, or the breakdown of red blood cells (hemolysis), which can cause sudden kidney damage.

"The data for Volt confirms what I see firsthand in the procedure room with this next-generation PFA device," said Atul Verma, M.D., director of the Division of Cardiology at McGill University Health Centre and McGill University in Montreal, Canada, who treated patients as part of the VOLT-AF IDE study and presented the late-breaking data at AF Symposium. "The system's unique design enables a high degree of freedom from AFib for patients, and its impressive safety profile reduces PFA-specific complications such as hemolysis, which negatively impacts other parts of the body." 

The Volt PFA System secured U.S. Food and Drug Administration (FDA) approval and CE Mark in Europe last year. Commercial cases have begun in the U.S. and expansion in Europe continues. 

Strong data supports TactiFlex Duo Ablation Catheter, Sensor Enabled
Six-month data presented from the FOCALFLEX Global CE Mark trial confirmed the safety and effectiveness of TactiFlex Duo for treating more complex cases of AFib. The trial found a clinically meaningful success rate (81%) of freedom from documented rhythm recurrence among PAF patients. ²

Patient self-reported quality-of-life scores also climbed from 64.4 to 86.4.² This data from more than 20 centers in the European Union, United Kingdom and Australia contributed to the device's recent CE Mark approval. 

TactiFlex Duo is designed for focal ablation, using a dual-energy platform, which gives physicians the ability to tailor AFib therapy delivery in two ways instead of a single energy mode. Experts use the catheter to target and treat an irregular heart rhythm with either extreme heat (radiofrequency) or high-energy electrical pulses (PFA) based on a patient's individual needs and anatomy, including the most challenging cases. 

In addition to the CE Mark study, Abbott also completed enrollment last year for the FLEXPULSE Global IDE trial to evaluate TactiFlex Duo as an AFib therapy. Last October, the FDA granted Breakthrough Device Designation for TactiFlex Duo to treat Ventricular Tachycardia – a potentially life-threatening fast heart rate requiring immediate medical attention – using PFA.

"With the rising rates of AFib around the world, data from the Volt PFA and TactiFlex Duo trials help empower physicians with further confidence in using these devices to treat people with AFib – from the recently diagnosed to the most complex cases," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business. "These studies help solidify our treatment offerings for AFib as we strive to challenge the status quo to develop even better tools that physicians can rely on to care for their patients." 

In addition, a late-breaking data presentation on Abbott's Amulet device will be presented on Friday, Feb. 6 between 5:30 – 7 p.m. Eastern from the VERITAS Amulet 360 Pivotal Study.

For U.S. important safety information go to:
Volt™ PFA System 
https://www.cardiovascular.abbott/us/en/ep-clinical-evidence/volt-clinical-evidence.html

TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ is approved for investigational use only in the U.S.

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 115,000 colleagues serve people in more than 160 countries. 

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

¹ Verma, A. (2026, February 5) 12-Month Safety and Effectiveness of a balloon-in-basket PFA system for de novo PVI to treat PAF and PsAF: Results from the VOLT-AF IDE Study [Late Breaking Presentation]. AF Symposium 2026, Boston MA, USA.
² Deisenhofer, I. (2026, February 5) Safety and Effectiveness of the TactiFlex Duo System: 6-Month Results of the FOCALFLEX Study [Late Breaking Presentation]. AF Symposium 2026, Boston MA, USA.

View original content:https://www.prnewswire.com/news-releases/late-breaking-data-presentations-showcase-the-safety-and-efficacy-of-abbotts-ablation-catheters-to-treat-people-with-atrial-fibrillation-302680826.html

SOURCE Abbott

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Abbott (ABT) report about the Volt PFA System 12-month results at AF Symposium on Feb 6, 2026?

Volt showed an 84.2% freedom-from-recurrence rate for paroxysmal AF and ~68% for persistent AF at 12 months. According to Abbott, the single-arm VOLT-AF IDE trial also reported less than 6% repeat ablation and substantial AFEQT quality-of-life score improvements.

How effective was Abbott's TactiFlex Duo catheter in the FOCALFLEX CE Mark trial presented Feb 6, 2026?

TactiFlex Duo achieved an 81% freedom-from-recurrence rate for paroxysmal AF at six months. According to Abbott, the study also showed AFEQT scores rising from 64.4 to 86.4 and contributed to the device receiving CE Mark approval.

Does Abbott's Volt PFA System have U.S. regulatory approval as of Feb 6, 2026?

Yes. According to Abbott, the Volt PFA System secured FDA approval and a CE Mark last year, and commercial U.S. cases have begun while European expansion continues.

Is TactiFlex Duo commercially available in the United States after the Feb 6, 2026 data presentation?

No. According to Abbott, TactiFlex Duo is approved for investigational use only in the U.S., though it has received CE Mark approval in Europe and related trial enrollment for a global IDE has completed.

What safety signals did Abbott report for Volt PFA and TactiFlex Duo at AF Symposium Feb 5–7, 2026?

Both devices demonstrated favorable safety; Volt reported zero esophageal injuries or hemolysis-related complications in the study. According to Abbott, FOCALFLEX six-month data also confirmed safety and effectiveness for complex AF cases.