Abbott receives CE Mark for the TactiFlex™ Duo Ablation Catheter to treat patients with abnormal heart rhythms

Rhea-AI Summary

Abbott (NYSE: ABT) received CE Mark on Jan 20, 2026 for the TactiFlex™ Duo Ablation Catheter, Sensor Enabled, enabling commercial use in the European Union for treating atrial fibrillation (AFib).

TactiFlex Duo delivers dual-energy therapy (radiofrequency and pulsed field ablation) and completed its first commercial EU cases this week. CE Mark was supported by the FOCALFLEX CE Mark study showing clinically meaningful safety and effectiveness. The catheter integrates with Abbott's EnSite™ X mapping system. Abbott previously secured Volt PFA System approvals in 2025 and obtained FDA Breakthrough Device designation for VT in Oct 2025.

Positive

• CE Mark approval for TactiFlex Duo on Jan 20, 2026
• First successful commercial EU cases completed this week
• FOCALFLEX study showed clinically meaningful safety and effectiveness
• Dual-energy catheter: radiofrequency and PFA modes
• Integrates with EnSite X 3D mapping system
• Volt PFA System received FDA and CE approvals in 2025

Negative

• None.

News Market Reaction

-0.51%

1 alert

-0.51% News Effect

On the day this news was published, ABT declined 0.51%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Pre-news price: $121.76 Daily move: -1.43% Today’s volume: 10,062,995 shares +5 more

8 metrics

Pre-news price $121.76 ABT price before CE Mark TactiFlex Duo announcement

Daily move -1.43% 24h price change prior to the news

Today’s volume 10,062,995 shares Trading volume vs 20-day average 6,022,013 (RVOL 1.67)

52-week range $111.02 – $141.23 Price 9.67% above low and 13.79% below high

AFib prevalence 8 million people Approximate number of Europeans over 65 living with AFib

Projection horizon 30 years Period over which AFib prevalence is expected to double

Volt PFA approvals year 2025 FDA and CE Mark approvals for Volt PFA System

VT breakthrough date October 2025 FDA Breakthrough Device Designation for VT treatment using PFA

Market Reality Check

Price: $108.77 Vol: Volume 10,062,995 vs 20-d...

high vol

$108.77 Last Close

Volume Volume 10,062,995 vs 20-day average 6,022,013 (relative volume 1.67) before this CE Mark news. high

Technical Price $121.76 was trading below the 200-day MA of $129.88 ahead of the announcement and 13.79% below the 52-week high.

Peers on Argus

Before this news, ABT was down 1.43% while key device peers were mixed: BSX -2.1...

Before this news, ABT was down 1.43% while key device peers were mixed: BSX -2.17%, MDT -1.95%, SNN -1.27%, versus modest gains in SYK (+0.61%) and EW (+0.21%). No momentum-flagged peers or same-day peer headlines were detected, pointing to a stock-specific setup rather than a coordinated sector move.

Historical Context

5 past events · Latest: Jan 05 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 05	Earnings call notice	Neutral	+1.1%	Scheduled announcement of Q4 2025 results and conference call details.
Jan 05	Digital health launch	Positive	+1.8%	Launch of Libre Assist AI feature to aid diabetes food decisions.
Dec 22	FDA device approval	Positive	-0.2%	FDA approval of Volt™ PFA System for atrial fibrillation treatment.
Dec 18	Pediatric device clearance	Positive	-1.3%	FDA clearance and CE Mark for Amplatzer Piccolo Delivery System.
Dec 12	Dividend increase	Positive	+1.8%	6.8% dividend raise to $0.63 per share, extending Dividend Aristocrat record.

Pattern Detected

Recent device and regulatory wins often saw mixed near-term reactions, with some positive innovations selling off while shareholder-friendly actions like dividend increases and digital product launches aligned with modest gains.

Recent Company History

Over the last few months, Abbott has reported several notable developments. On Dec. 12, 2025, it announced a 6.8% dividend increase to $0.63 per share, its 54th consecutive annual raise, which coincided with a 1.77% gain. Regulatory milestones included FDA clearance and CE Mark for the Amplatzer Piccolo Delivery System and FDA approval of the Volt™ PFA System for atrial fibrillation. Digital expansion continued with the Libre Assist AI feature launch on Jan. 5, 2026. Today’s CE Mark for TactiFlex Duo extends this electrophysiology and AFib treatment trajectory.

Market Pulse Summary

This announcement extends Abbott’s strategy in cardiac rhythm management, adding a dual-energy Tacti...

Analysis

This announcement extends Abbott’s strategy in cardiac rhythm management, adding a dual-energy TactiFlex Duo catheter with both radiofrequency and pulsed field ablation capabilities, supported by the FOCALFLEX CE Mark study. Together with the Volt PFA System approvals in 2025 and FDA Breakthrough Device Designation for ventricular tachycardia, the news highlights a growing electrophysiology platform. Investors may watch upcoming U.S. FLEXPULSE IDE results, adoption trends in Europe, and integration with the EnSite X system as key follow-ups.

Key Terms

pulsed field ablation, radiofrequency energy, atrial fibrillation, ventricular tachycardia, +4 more

8 terms

pulsed field ablation medical

"It can deliver both radiofrequency energy and pulsed field ablation (PFA) energy..."

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.

radiofrequency energy medical

"TactiFlex Duo is designed to deliver tailored therapy lesions in two ways: radiofrequency energy..."

Radiofrequency energy is a type of electromagnetic power, similar to the waves used in radio and Wi‑Fi, that medical devices convert into controlled heat to treat or alter body tissue without cutting. Investors should care because devices that use this energy—for example to seal blood vessels, destroy tumors, or reshape tissue—can drive sales, face safety and regulatory scrutiny, and affect reimbursement and patent value, all of which influence a medical-device maker’s financial outlook.

atrial fibrillation medical

"to treat patients with atrial fibrillation (AFib). Following the new approval..."

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.

ventricular tachycardia medical

"Breakthrough Device Designation for the treatment of ventricular tachycardia (VT) using PFA."

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.

breakthrough device designation regulatory

"the FDA granted it Breakthrough Device Designation for the treatment of ventricular tachycardia..."

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.

ce mark regulatory

"Abbott today announced it has received CE Mark in Europe for the TactiFlex Duo..."

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.

ide trial regulatory

"Enrollment for Abbott's FLEXPULSE IDE trial to evaluate TactiFlex Duo..."

An IDE trial is a regulated clinical study that lets a company test a medical device in patients under an Investigational Device Exemption from the U.S. regulator; it’s essentially a formal permit to gather safety and effectiveness data before broad commercial approval. For investors, an IDE trial is a major de-risking step and milestone—successful results move a device closer to market approval and revenue, while delays or negative outcomes can materially affect a company’s value, similar to how a road-test permit lets a car maker prove a new model is safe before mass production.

electrophysiology medical

"third significant approval in Abbott's electrophysiology portfolio in less than a year."

The study and measurement of the electrical signals that control cells and tissues, most commonly used to diagnose and treat heart rhythm problems and to test how nerves and muscles communicate. Investors care because electrophysiology drives products, procedures and drugs—like monitoring systems, catheter tools and implants—that can alter a medical device or drug maker’s sales, regulatory approvals and clinical trial outcomes; think of it as checking and fixing the wiring that makes the body run.

AI-generated analysis. Not financial advice.

• Abbott's TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, is designed with dual-energy to treat atrial fibrillation patients with the most challenging cases
• It can deliver both radiofrequency energy and pulsed field ablation (PFA) energy during procedures to target and treat an irregular heart rhythm
• The availability of TactiFlex Duo in Europe adds a dual-energy, focal ablation catheter to Abbott's growing PFA portfolio, following the company's Volt PFA System approvals in the U.S. and Europe last year

ABBOTT PARK, Ill., Jan. 20, 2026 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it has received CE Mark in Europe for the TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ to treat patients with atrial fibrillation (AFib). Following the new approval, the first successful commercial cases using TactiFlex Duo in the European Union were completed this week.

Abbott's TactiFlex Duo Catheter is the latest advancement in the company's pulsed field ablation (PFA) technology portfolio. An effective cardiac ablation – a minimally invasive procedure to stop an irregular heart rhythm – relies on the quality of the scars (lesions) created by a catheter to stop the source of an arrhythmia. TactiFlex Duo is designed to deliver tailored therapy lesions in two ways: radiofrequency energy (uses heat to destroy tissue responsible for erratic heart signals), and pulsed field ablation energy (uses high energy electrical pulses to destroy the cells causing abnormal heart rhythms, which can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy).

"TactiFlex Duo's most unique feature is its dual options that allow physicians to seamlessly switch treatment during a procedure based on the patient's personalized needs and anatomy," said Prof. Isabel Deisenhofer, M.D., head of the department of Electrophysiology at the German Heart Center Munich in Germany, and one of the first physicians to use TactiFlex Duo following CE Mark approval. "For patients who do not respond to medication and other traditional treatments, a successful cardiac ablation is critical as it can reduce the risk of recurrence of AFib and provide long-lasting relief."

TactiFlex Duo Supported by Strong Data
CE Mark approval for the TactiFlex Duo Ablation Catheter was supported by data from Abbott's FOCALFLEX CE Mark study, a global clinical trial conducted at centers in the European Union, United Kingdom and Australia. The trial showed that TactiFlex Duo demonstrated clinically meaningful performance in the safety and effectiveness of treating patients with AFib¹.

Approximately eight million Europeans over the age of 65 are living with AFib, a number expected to double over the next 30 years^2,3. People living with AFib face an increased risk of stroke, heart failure and death, and many rely on cardiac ablation to treat the condition effectively.

"AFib is a progressive disease that becomes harder to treat over time, and there is not a one-size-fits all approach, which makes long-term management complex," said John Silberbauer, M.D., electrophysiologist at the Sussex Cardiac Centre in Brighton, United Kingdom, who treated patients as part of the FOCALFLEX study. "TactiFlex Duo allows me to safely tailor each ablation treatment to the patient's anatomy, and results show that it consistently improves symptoms and quality of life for many."

TactiFlex Duo integrates with Abbott's EnSite™ X EP System, which creates highly detailed three-dimensional maps of the heart to help doctors find and treat the source of the arrhythmia. The technology builds on the catheter's previous generation flexible electrode tip and contact force sensing to now include PFA energy delivery, resulting in more effective and safer procedures⁴.

Significant Regulatory Progress Across Abbott's PFA Portfolio
TactiFlex Duo marks the third significant approval in Abbott's electrophysiology portfolio in less than a year. The company's Volt PFA System received FDA and CE Mark approvals in 2025.

"The TactiFlex Duo Catheter provides another advanced tool to Abbott's growing PFA portfolio for treating patients with more complex cases such as those with co-existing heart disease and heart failure, long-lasting AFib, ventricular arrhythmias and patients with a history of failed ablations," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business. "By focusing on a holistic view of patient care, physicians now have multiple clinically proven tools to enhance workflow and to effectively treat a wide range of arrhythmias."

Enrollment for Abbott's FLEXPULSE IDE trial to evaluate TactiFlex Duo for the treatment of AFib in the United States was completed last year. In October 2025, the FDA granted it Breakthrough Device Designation for the treatment of ventricular tachycardia (VT) using PFA. To qualify for this breakthrough designation, products must address an unmet need and show it has the potential to provide more effective treatment of life-threatening diseases. VT is a fast heart rate that can be life-threatening and requires immediate attention.  

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

EnSite™ X EP System
https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x.html

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. 

¹ Abbott FOCALFLEX Trial Data on File, November 2025
²Fact Sheets for Press. European Society of Cardiology. (n.d.-a). https://www.escardio.org/The-ESC/Press-Office/Factsheets
³Atrial fibrillation set to affect more than 14 million over-65s in the EU by 2060. European Society of Cardiology. (n.d.). https://www.escardio.org/The-ESC/Press-Office/Press-releases/Atrial-fibrillation-set-to-affect-more-than-14-million-over-65s-in-the-EU-by-2060
⁴ Abbott FOCALFLEX Trial Data on File, November 2025

View original content:https://www.prnewswire.com/news-releases/abbott-receives-ce-mark-for-the-tactiflex-duo-ablation-catheter-to-treat-patients-with-abnormal-heart-rhythms-302664888.html

SOURCE Abbott

FAQ

What did Abbott (ABT) announce on January 20, 2026 about TactiFlex Duo?

Abbott announced CE Mark approval for the TactiFlex Duo Ablation Catheter and reported the first successful commercial EU cases.

How does the TactiFlex Duo catheter treat AFib and what energies does it use?

TactiFlex Duo delivers both radiofrequency energy and pulsed field ablation (PFA) energy to create tailored lesions for AFib treatment.

What clinical evidence supported CE Mark for TactiFlex Duo (ABT)?

CE Mark approval was supported by the global FOCALFLEX CE Mark study, which showed clinically meaningful performance in safety and effectiveness.

Will TactiFlex Duo work with Abbott's mapping systems for procedures?

Yes; TactiFlex Duo integrates with the EnSite X EP System to provide detailed 3D heart mapping during ablation procedures.

What other Abbott electrophysiology milestones preceded the TactiFlex Duo CE Mark?

Abbott's Volt PFA System received FDA and CE approvals in 2025, and the company received FDA Breakthrough Device designation for VT in Oct 2025.

Is Abbott studying TactiFlex Duo in the U.S. and for other indications?

Enrollment for the U.S. FLEXPULSE IDE trial was completed in 2025, and the device has Breakthrough Device designation for ventricular tachycardia.