Abbott's Volt™ Pulsed Field Ablation System Receives FDA Approval to Treat Patients with Atrial Fibrillation

Abbott (NYSE: ABT) announced FDA approval of its Volt™ Pulsed Field Ablation (PFA) System to treat atrial fibrillation on Dec 22, 2025.

Rhea-AI Summary

Abbott (NYSE: ABT) announced FDA approval of its Volt™ Pulsed Field Ablation (PFA) System to treat atrial fibrillation on Dec 22, 2025. Approval was based on the VOLT-AF IDE study of 392 patients across 40 centers in the U.S., Europe, Canada and Australia, showing clinically meaningful safety and effectiveness for both paroxysmal and persistent AFib. Volt is an all-in-one PFA catheter with a proprietary balloon-in-basket design, integration with Abbott’s EnSite X mapping system, fewer therapy applications, reduced fluoroscopy, and the option for procedures under conscious sedation. Abbott will begin U.S. commercial cases and continue EU site expansion.

Positive

• FDA approval received on Dec 22, 2025
• VOLT-AF IDE study enrolled 392 patients at 40 centers
• Designed for conscious sedation, potentially shorter procedures and faster recovery

Negative

• None.

Argus Dec 22 session

-0.20% close to close Open Argus

Details

News Market Reaction – ABT

In the Dec 22 session, ABT declined 0.20%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement details FDA approval of Abbott’s Volt™ Pulsed Field Ablation System for atrial fib...

Analysis

This announcement details FDA approval of Abbott’s Volt™ Pulsed Field Ablation System for atrial fibrillation, supported by the 392-patient VOLT-AF IDE study across 40 centers. It expands a 2025 track record that already includes other cardiovascular device approvals and a 6.8% dividend increase. Investors may focus on adoption versus existing AFib treatments, procedure workflow benefits, and how this integrates with systems like EnSite™ X, alongside overall device segment performance in upcoming filings.

Key Figures

VOLT-AF IDE sample size: 392 patients Study centers: 40 centers AFib prevalence U.S.: 12 million people +5 more

VOLT-AF IDE sample size

392 patients

VOLT-AF IDE study supporting Volt PFA FDA approval

Study centers

40 centers

Sites in U.S., Europe, Canada, Australia for VOLT-AF IDE

AFib prevalence U.S.

12 million people

People over 65 with atrial fibrillation in the United States

AFib prevalence outlook

Expected to double in 20 years

Projected AFib burden in the United States

Stroke risk increase

Fivefold increased risk

Stroke risk among people living with AFib

Dividend increase

6.8%

Increase in quarterly dividend announced Dec 12, 2025

New quarterly dividend

$0.63 per share

Quarterly dividend payable Feb 13, 2026

Q3 2025 net sales

$11,369 million

Net sales for Q3 2025 from 10-Q filing

Historical Context

5 past events · Latest: Dec 18

5 events

1. Dec 18

   Pediatric device clearance

   24h Move

   -1.3%

   FDA clearance and CE Mark for Amplatzer Piccolo delivery system.

2. Dec 12

   Dividend increase

   24h Move

   +1.8%

   Quarterly dividend raised 6.8% to $0.63 per share.

3. Dec 08

   Consumer device expansion

   24h Move

   -2.4%

   Lingo glucose monitoring expanded to Android in U.S. and U.K.

4. Dec 06

   CSR blood drive update

   24h Move

   -2.4%

   We Give Blood campaign donations surged 319% versus 2024.

5. Dec 04

   Nutrition product launch

   24h Move

   +0.1%

   Launch of two Ensure Max Protein shakes focused on muscle health.

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, cardiac ablation, conscious sedation, +4 more

8 terms

pulsed field ablation medical

"Pulsed field ablation – or PFA – is a minimally invasive procedure..."

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

"designed for people battling heart rhythm disorders such as 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.

cardiac ablation medical

"rely on a minimally invasive cardiac ablation procedure to effectively treat the condition"

Cardiac ablation is a medical procedure that uses heat, cold, or energy to destroy small areas of heart tissue that cause abnormal electrical signals and irregular heartbeats. For investors, it matters because the procedure drives demand for specialized medical devices, hospital services, and ongoing treatment revenues, and changes in its safety, effectiveness, or insurance coverage can materially affect companies and clinical adoption—think of it as targeted surgery that resets a misfiring circuit in the heart.

conscious sedation medical

"patients...can be placed under conscious sedation instead of general anesthesia"

Conscious sedation is a medically controlled state where a patient is relaxed, drowsy and comfortable but still awake enough to respond to verbal cues and breathe without assistance. Think of it like being pleasantly tipsy during a short procedure rather than fully asleep. For investors, it matters because the technique affects procedure time, recovery speed, staffing needs, equipment and drug demand, and legal or reimbursement risks that influence healthcare costs and provider revenues.

general anesthesia medical

"an alternative to general anesthesia during a PFA ablation procedure"

General anesthesia is a medically induced, reversible state of unconsciousness, loss of pain sensation, and muscle relaxation used during major surgeries so patients do not feel or remember the procedure. For investors, it matters because its use affects hospital and surgical center revenue, drug and equipment demand, operating-room scheduling, procedure risk profiles and recovery times, all of which influence costs, reimbursement rates, liability exposure and overall healthcare spending trends.

fluoroscopy medical

"The Volt PFA System also reduces exposure to radiation (fluoroscopy)"

Fluoroscopy is a medical imaging method that creates live X‑ray “video” of the inside of the body, allowing doctors to watch organs, bones, and instruments move during procedures, like viewing a real‑time map while driving. Investors care because fluoroscopy drives demand for imaging equipment, disposable supplies and procedure-related services, influences regulatory approvals and reimbursement rates, and affects clinical adoption that can shape revenues and costs in healthcare companies.

hemolysis medical

"reduces exposure to radiation (fluoroscopy) and limits the breakdown of red blood cells (hemolysis)"

Hemolysis is the breaking apart of red blood cells so that their contents leak into the bloodstream, like a burst water balloon spilling its load. It matters to investors because hemolysis can harm patients, skew lab test results, complicate clinical trial data and safety reviews, and trigger additional testing, regulatory scrutiny, product changes or recalls—outcomes that can affect a healthcare or diagnostics company's revenue and stock value.

3D cardiac mapping medical

"designed to integrate with Abbott's EnSite X EP System by providing physicians accurate 3D cardiac mapping"

A technology that creates a detailed three-dimensional map of the heart’s anatomy and electrical signals to guide doctors during diagnosis and treatment of abnormal heart rhythms. Think of it as a GPS for the heart that helps locate problem spots, steer treatment tools more precisely, shorten procedure time and improve outcomes — factors that can affect device and software sales, procedure volumes, regulatory approvals and overall healthcare costs, which investors care about.

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

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• Abbott's Volt™ PFA System, the latest generation of cardiac ablation technology, is designed for people battling heart rhythm disorders such as atrial fibrillation (AFib)
• Pulsed field ablation – or PFA – is a minimally invasive procedure that uses high-energy electrical pulses in targeted areas of the heart to treat irregular heart rhythms
• Abbott's Volt PFA System is an all-in-one product that is clinically proven to simplify the treatment of AFib that is gentler on the heart, has shorter procedure times and supports better recovery and long-term results

ABBOTT PARK, Ill., Dec. 22, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved the company's Volt™ PFA System to treat patients battling atrial fibrillation (AFib). Abbott will soon begin commercial PFA cases in the United States and will continue its expansion of sites in the European Union following Volt CE Mark approval earlier this year.

Approximately 12 million people in the United States over the age of 65 have AFib, a number expected to double over the next 20 years¹. People living with AFib face a fivefold increased risk of stroke, and the condition has been a contributing cause of death for more than two decades in the United States². When medication and other treatment options fail to work, many patients rely on a minimally invasive cardiac ablation procedure to effectively treat the condition by stopping irregular heart rhythms.

Volt Demonstrates Strong Patient Outcomes for Abnormal Heart Rhythms 
FDA approval for the Volt PFA System was secured based on strong results from Abbott's VOLT-AF IDE study, a clinical trial of 392 patients conducted at 40 centers in the United States, Europe, Canada and Australia. The data showed that the Volt PFA System demonstrated clinically meaningful performance in both safety and effectiveness 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.

"AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life. When I perform a cardiac ablation, I look for a tool with an excellent patient safety profile that can simplify the treatment of AFib," said DJ Lakkireddy, M.D., executive medical director of the Kansas City Heart Rhythm Institute and one of the first physicians to use Volt in the United States. "Volt is a promising option for patients. Its real-time contact visualization and unique balloon-in-basket design provide superior tissue contact and focused energy delivery, while addressing some of the limitations of the early generation PFA systems."

Volt PFA System: Designed with Physician Feedback in Mind 
Abbott's Volt PFA System builds upon the company's leading electrophysiology portfolio by providing an all-in-one product that allows physicians to safely map, pace and ablate with the same catheter. Volt's proprietary balloon-in-basket design features multiple handling options for ease of use and allows for efficient energy transfer directly to the targeted tissue to stop the heart's erratic signals.

With improved physician workflow in mind, Volt's PFA System was designed to integrate with Abbott's EnSite™ X EP System by providing physicians accurate 3D cardiac mapping and fewer catheter exchanges during an ablation. While current on-market competitive PFA systems often require several therapy applications with a catheter positioned in various locations, the Volt PFA System integration with EnSite X was designed to address such limitations and has been clinically proven to provide:

• Minimal number of therapy applications and enhanced patient outcomes. The Volt PFA System is designed to deliver precise, targeted energy during ablation, which helps achieve durable lesions with fewer pulses. This level of accuracy supports effective first-time procedures, reducing the likelihood of repeat ablations and minimizing the risk of complications.
• More procedural options for patients. Patients who undergo a minimally invasive ablation procedure with the Volt PFA Catheter can be placed under conscious sedation instead of general anesthesia, which is a significant benefit for patients where anesthesia is a barrier to performing ablations. The Volt PFA System also reduces exposure to radiation (fluoroscopy) and limits the breakdown of red blood cells (hemolysis).

"We heard the physician feedback that patients need an alternative to general anesthesia during a PFA ablation procedure that doesn't sacrifice strong outcomes," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business. "The Volt PFA System is an option for patients who prefer conscious sedation, which can also lead to faster recovery times and shorter procedures for the millions of Americans who suffer from an abnormal heart rhythm."

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

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 CDC. Atrial Fibrillation Fact Sheet.  https://www.cdc.gov/heartdisease/atrial_fibrillation.htm, 8 Sept. 2020. Accessed 19 Sept. 2020.
² CDC. About Atrial Fibrillation. About Atrial Fibrillation | Heart Disease | CDC, 8 Oct. 2025. Accessed 15 Oct. 2025.

View original content:https://www.prnewswire.com/news-releases/abbotts-volt-pulsed-field-ablation-system-receives-fda-approval-to-treat-patients-with-atrial-fibrillation-302647634.html

SOURCE Abbott

FAQ

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

What did Abbott announce about the Volt PFA System on Dec 22, 2025 (ABT)?

Abbott announced FDA approval of the Volt PFA System to treat atrial fibrillation and plans to begin U.S. commercial cases.

What clinical evidence supported FDA approval of Abbott's Volt PFA System (ABT)?

Approval was based on the VOLT-AF IDE study of 392 patients conducted at 40 centers across the U.S., Europe, Canada and Australia showing safety and effectiveness.

How does the Volt PFA System (ABT) differ from earlier PFA devices?

Volt uses a proprietary balloon-in-basket design, integrates with EnSite X mapping, aims for fewer therapy applications and reduced fluoroscopy.

Will Abbott’s Volt PFA System (ABT) allow procedures without general anesthesia?

Yes. The Volt PFA System is designed to enable procedures under conscious sedation as an alternative to general anesthesia.

When will Abbott (ABT) start commercial U.S. cases for Volt?

Abbott said it will soon begin commercial PFA cases in the United States following FDA approval.