Abbott receives FDA approval for its TactiFlex™ Duo Ablation Catheter to treat people with abnormal heart rhythms

FDA clearance of TactiFlex Duo adds a dual‑energy PFA/RF option for U.S. electrophysiologists treating complex atrial fibrillation.

Rhea-AI Summary

Abbott (ABT) received U.S. FDA approval on Sept. 8, 2026 for its TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, to treat atrial fibrillation (AFib), including challenging cases.

The latest generation catheter combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single device, allowing physicians to use either or both during a procedure to tailor therapy and create precise lesions while helping spare surrounding tissue. TactiFlex Duo works with Abbott’s EnSite™ X EP System, which provides high‑resolution 3D cardiac mapping and a PFA Index (PI) tool to assess lesion formation in real time. FDA approval is supported by safety and effectiveness data from the FlexPulse IDE study in paroxysmal AFib. Abbott expects to begin U.S. cases and broader commercial adoption in the coming weeks, adding a fifth major electrophysiology approval to its expanding global PFA‑based portfolio.

Positive

• FDA approval of TactiFlex Duo for treating atrial fibrillation in the U.S.
• Dual‑energy design combines PFA and RF in a single ablation catheter
• FlexPulse IDE study data supported safety and effectiveness in paroxysmal AFib
• Fifth major EP approval in just over a year, expanding Abbott’s PFA portfolio

Negative

• None.

Market Context

On Dec 22, 2025, Abbott's Volt FDA approval had a recorded -0.2% 24-hour reaction; the same AFib PFA...

Analysis

On Dec 22, 2025, Abbott's Volt FDA approval had a recorded -0.2% 24-hour reaction; the same AFib PFA category provides a direct regulatory precedent, while ABT stood at -0.42% pre-headline.

Key Figures

Electrophysiology approvals: 5 major approvals

Electrophysiology approvals

5 major approvals

Abbott portfolio in just over a year

Previous Fda approval Reports

1 past event · Latest: Dec 22

Same Type 1 event

1. Dec 22

   FDA approval

   24h Move

   -0.2%

   FDA approval for an AFib PFA system supported by a 392-patient, 40-center IDE study

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, radiofrequency, atrial fibrillation, intracardiac echocardiography, +1 more

5 terms

pulsed field ablation medical

"combines pulsed field ablation (PFA) and radiofrequency (RF) 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 medical

"pulsed field ablation (PFA) and radiofrequency (RF) energy"

Radiofrequency is a band of electromagnetic energy, like invisible waves of heat or radio music, used to carry signals and to deliver controlled heating in medical or industrial devices. Investors care because technologies that use these waves—from wireless networks to surgical tools that remove tissue or stop bleeding—can drive product sales, regulatory review, and market value; think of it as a core ingredient that enables certain devices or services to work.

atrial fibrillation medical

"treat patients with challenging cases of 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.

intracardiac echocardiography medical

"ViewFlex™X ICE (intracardiac echocardiography) catheter"

A type of medical imaging where a small ultrasound probe is threaded into the heart on a thin tube to take real‑time pictures from inside the body, like moving a camera into a machine to see its parts up close. Investors care because this tool can improve the safety, speed and success of cardiac procedures, affecting demand for the device makers, hospital costs, procedure volumes and potential regulatory or reimbursement outcomes.

IDE study regulatory

"results from Abbott's FlexPulse IDE study"

An IDE study is a regulated clinical trial that allows a medical device to be tested in people under an Investigational Device Exemption from the U.S. Food and Drug Administration, so firms can gather safety and effectiveness data before full market approval. For investors, an IDE study is like a controlled test drive and safety inspection: positive results move a device closer to commercial sales and can boost a company’s value, while setbacks can sharply reduce its prospects.

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

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• Abbott's TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single catheter to treat complex atrial fibrillation (AFib) cases
• Strong clinical evidence demonstrates the device's high rates of safety and effectiveness in treating AFib patients
• FDA approval of TactiFlex Duo strengthens Abbott's expanding PFA portfolio following recent cardiac ablation approvals in the U.S., Europe, Asia and Latin America

ABBOTT PARK, Ill., Sept. 8, 2026 /PRNewswire/ -- Abbott, the global healthcare leader, announced today it has received U.S. Food and Drug Administration (FDA) approval for the TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ to treat patients with challenging cases of atrial fibrillation (AFib). The U.S. approval of this dual-energy catheter, the latest generation of Abbott's cardiac ablation technology, marks a significant milestone in Abbott's commitment to advancing therapies that help physicians treat complex heart rhythms with greater precision and flexibility. Abbott will soon begin cases with broader commercial adoption across the country in the coming weeks.

Why cardiac ablation matters for people with AFib
For the 10.5 million people in the U.S. who live with a heart that beats too fast, too slow or in an irregular way, treatment is critical as AFib increases the risk of serious complications, including stroke.^1,2 While many people are treated with medications, others require cardiac ablation, a minimally invasive procedure that targets the tissue responsible for abnormal electrical signals in the heart.

TactiFlex Duo is Abbott's latest ablation catheter designed to give physicians more flexibility when treating AFib. The technology allows physicians to use pulsed field ablation (PFA), radiofrequency (RF) energy, or a combination of both during a procedure, helping them tailor treatment to each patient's needs. Abbott's EnSite™ X EP System also provides physicians with real-time feedback as an integrated mapping solution with the PFA Index (PI), a tool designed to assess lesion formation during ablation with TactiFlex Duo. The dual-energy approach means physicians can create precise therapeutic lesions, or small areas of scar tissue, that block the abnormal electrical signals causing an irregular heartbeat while helping minimize the impact on surrounding healthy tissue. Successfully treating these areas can help restore the heart's normal rhythm and improve outcomes for patients living with AFib. 

"Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment," said Atul Verma, M.D., Director of Cardiology at the McGill University Health Centre in Montreal, Canada, and a globally recognized expert in pulsed field ablation technology. "TactiFlex Duo provides physicians with greater flexibility during procedures, and when it is combined with the high-resolution 3D visualization available through Abbott's EnSite X mapping system, physicians have a suite of practice-changing tools to confidently treat patients with complex AFib."

Safety and effectiveness data support TactiFlex Duo FDA approval  
The FDA approval of TactiFlex Duo was secured based on the results from Abbott's FlexPulse IDE study. Late-breaking data from the study recently presented at the European Society of Cardiology (ESC) Congress 2026, which was simultaneously published in EP Europace, showed favorable safety and effectiveness outcomes in patients with paroxysmal AFib (irregular heart rhythm episodes that come and go).

"TactiFlex Duo represents an important advancement as Abbott builds the industry's most comprehensive electrophysiology portfolio," said Uri Yaron, senior vice president of Abbott's electrophysiology business. "From diagnosis, mapping and intracardiac ultrasound imaging to advanced treatments for the most complex arrhythmias, Abbott is uniquely positioned to support physicians at every stage of patient care. By continuing to expand our PFA portfolio and integrate innovative technologies across cardiovascular care, we're helping physicians navigate increasingly complex procedures while ensuring more patients receive the right care at the right time."

Regulatory momentum across Abbott's PFA portfolio
The U.S. FDA approval of TactiFlex Duo further expands Abbott's portfolio of technologies designed to help physicians treat patients with cardiac arrhythmias. It is the company's fifth major electrophysiology approval in just over a year, following Europe's Amulet 360™ and TactiFlex Duo CE Mark approvals this year, and U.S. and European approvals of the Volt™ PFA System in 2025.

Frequently Asked Questions

What is TactiFlex Duo?
TactiFlex Duo is an advanced cardiac ablation catheter designed to treat irregular heart rhythms. Its dual-energy feature combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single device, allowing physicians to tailor treatment to each patient's unique needs during AFib ablation procedures.  

How do physicians know the precise locations in the heart to treat patients with TactiFlex Duo?  
TactiFlex Duo is integrated with Abbott's EnSite X EP System, a sophisticated mapping system that creates highly detailed three-dimensional maps of the heart to help doctors find and treat the source of an irregular heartbeat. Working together with Abbott's Advisor™ HD Grid X mapping catheter, ViewFlex™X ICE (intracardiac echocardiography) catheter and EnSite Echo Module, the integrated portfolio is designed to give physicians real-time images of the ablation catheter's positioning and movement, and a digital model of the patient's heart throughout a procedure. The EnSite X EP System also provides physicians with real-time information – called PFA index – which shows how the small areas of scar tissue created by TactiFlex Duo's pulsed field energy develop during an ablation procedure.³ 

Who may need an ablation using TactiFlex Duo?
Patients with atrial fibrillation, particularly those with complex anatomy, prior or failed ablations or other challenging clinical situations, may benefit from treatment with TactiFlex Duo as determined by their physician. 

What are the patient benefits of being treated with TactiFlex Duo?
The catheter offers physicians greater procedural flexibility and precision through dual-energy capabilities, helping treat irregular heart rhythms while reducing the potential for damage to surrounding tissue. Clinical data has shown the technology to be safe and effective.

For U.S. important safety information go to:

TactiFlex Duo Ablation Catheter, Sensor Enabled

Volt™ PFA System

EnSite™ X EP System 

Advisor HD Grid X Mapping Catheter, Sensor Enabled™

ViewFlex X ICE Catheter, Sensor Enabled™ and EnSite Echo Module

The Amulet 360™ Left Atrial Appendage Occluder 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 3 medicines. Our 122,000 colleagues serve people in more than 160 countries.

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

________________________________

1 Noubiap JJ, Tang JJ, Teraoka JT, Dewland TA, Marcus GM. Minimum National Prevalence of Diagnosed Atrial Fibrillation Inferred From California Acute Care Facilities. J Am Coll Cardiol. 2024;84(16):1501-1508. doi:10.1016/j.jacc.2024.07.014.

2 About Atrial Fibrillation. Centers for Disease Control. (n.d.). About Atrial Fibrillation | Heart Disease | CDC.

3 Friedman, et al. (2025 September) Development of a PFA index to guide energy delivery with a force sensing flexible, irrigated tip catheter [Oral presentation]. ESC 2025, Madrid, Spain.

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SOURCE Abbott

FAQ

What is TactiFlex Duo and how does its dual‑energy feature work?

TactiFlex™ Duo is an advanced cardiac ablation catheter designed to treat irregular heart rhythms such as atrial fibrillation. Its dual‑energy feature lets physicians deliver pulsed field ablation (PFA), radiofrequency (RF) energy, or a combination of both in a single procedure. This allows them to tailor energy delivery to each patient’s anatomy and clinical situation while creating lesions that block abnormal electrical signals and aim to limit impact on surrounding healthy tissue.

How do physicians locate and monitor ablation targets when using TactiFlex Duo?

TactiFlex Duo is integrated with Abbott’s EnSite™ X EP System, which generates detailed 3D maps of the heart to help identify the sources of abnormal rhythms. Used with the Advisor™ HD Grid X mapping catheter, ViewFlex™ X ICE catheter and EnSite Echo Module, the system provides real‑time images of catheter position and a digital heart model during the procedure. EnSite X also supplies a PFA Index, showing how lesions created by TactiFlex Duo’s pulsed field energy are developing during ablation.

Which patients may be candidates for ablation using TactiFlex Duo?

Patients with atrial fibrillation, particularly those with complex anatomy, prior or failed ablations, or other challenging clinical situations, may benefit from treatment with TactiFlex Duo, as determined by their physician.

What potential benefits does TactiFlex Duo offer to patients and physicians?

The catheter offers greater procedural flexibility and precision by combining PFA and RF capabilities. This design helps physicians treat irregular heart rhythms while reducing the potential for damage to surrounding tissue. Clinical data cited by the company have shown the technology to be safe and effective in AFib ablation.

How does this approval fit within Abbott’s broader electrophysiology and PFA portfolio?

The TactiFlex Duo FDA approval is Abbott’s fifth major electrophysiology approval in a little over a year. It follows CE Mark approvals in Europe for Amulet 360™ and TactiFlex Duo in 2026, and U.S. and European approvals of the Volt™ PFA System in 2025. The company states that these technologies, alongside EnSite X mapping and associated catheters, are intended to create a comprehensive portfolio for diagnosing, mapping and treating complex cardiac arrhythmias.