First Canadian Commercial Use of Abbott's Volt™ Pulsed Field Ablation System Advances Minimally Invasive Atrial Fibrillation Care

• Abbott's Volt™ Pulsed Field Ablation System is the next generation of cardiac ablation technology built on a distinctive balloon-in-basket design to treat people with heart rhythm disorders such as atrial fibrillation (AFib)
• The McGill University Health Centre in Montreal is the first in Canada to use the system to treat its patients with AFib
• Pulsed field ablation (PFA) is a minimally invasive procedure that uses high-energy electrical pulses in targeted areas of the heart to treat irregular heart rhythms

MISSISSAUGA, ON, Sept. 15, 2026 /CNW/ -- Abbott (NYSE: ABT) today announced that its Volt™ Pulsed Field Ablation System, designed to deliver more precise, targeted energy with fewer catheter exchanges and reduced radiation exposure than earlier-generation systems, was used for the first time in Canada at the McGill University Health Centre in Montreal to treat patients with atrial fibrillation (AFib).

"Atrial fibrillation doesn't stand still--earlier intervention means we have a better chance of improving long-term outcomes for our patients. In practice, we're looking for technologies that are not only safe, but that can help make procedures more consistent and efficient. Innovations like Volt are notable for combining real-time feedback with a distinctive catheter design, which may help optimize contact and energy delivery during procedures." said Dr. Atul Verma, M.D., director of cardiology at the McGill University Health Centre in Montreal.

Understanding Atrial Fibrillation

AFib is a type of irregular heart rhythm, also known as an arrhythmia, that affects between 500,000 to nearly one million Canadians.¹ If left untreated, AFib can lead to serious complications including:²

• Stroke: People with atrial fibrillation have 3 to 5 times greater risk for ischemic stroke because during AFib, the atria contract chaotically and blood pools in the grooves of the heart, forming clots that can travel to the brain. An ischemic stroke occurs when blood flow to the brain is interrupted by a clot in a blood vessel in the brain. It is estimated that one fourth of all strokes after age 40 are caused by AFib.
• Heart Failure: Chronic AFib can weaken the heart muscle over time, leading to heart failure and reduced quality of life.

Cardiac ablation is a minimally invasive treatment option for patients whose AFib isn't controlled by medication; it works by safely destroying (ablating) small, targeted areas of heart tissue that are causing irregular heart rhythms, which can make the heart beat too fast, too slow, or irregularly.

Clinical Evidence: The VOLT-AF IDE Study

Health Canada authorization of the Volt PFA System was based on strong results from Abbott's VOLT-AF IDE study, a comprehensive clinical trial of 392 patients conducted at 40 centres in the United States, Europe, Canada and Australia.^3,4 

The VOLT-AF IDE study demonstrated clinically meaningful performance in both safety and effectiveness in treating two distinct patient groups:⁴

• Paroxysmal AFib (PAF): Irregular heart rhythm episodes that come and go.
• Persistent AFib (PersAF): Episodes that last longer than seven days.

Key Clinical Advantages of the Volt System

The Volt PFA System is designed to integrate with Abbott's EnSite™ X EP System to provide physicians with accurate 3D cardiac mapping and fewer catheter exchanges during an ablation.^5,6 While other in-market competitive PFA systems often require several therapy applications with a catheter positioned in various locations, the Volt PFA System integration with EnSite X addresses such limitations.

Based on VOLT-AF IDE clinical data, the Volt System delivers the following benefits:

• Precise Energy Delivery with Fewer Applications: The Volt PFA System is designed to deliver precise, targeted energy during an ablation procedure, which helps achieve durable lesions with fewer pulses. A durable lesion is a small, intentional scar in the heart that, over time, blocks abnormal electrical signals that cause AFib. Volt's balloon-in-basket catheter is designed to maximize tissue contact and focus pulsed-field energy on the intended cardiac tissue, allowing physicians to achieve durable ablation lesions with fewer therapy applications and potentially reducing the need for repeat procedures. This level of accuracy supports effective first-time procedures, reducing the likelihood of repeat ablations and minimizing the risk of complications.^7-10
• Conscious Sedation Option: Patients who undergo ablation with the Volt PFA Catheter can be treated under conscious sedation as an alternative to general anesthesia, which is a significant benefit for patients where anesthesia is a barrier to treatment.^11,12
• Reduced Radiation Exposure: The Volt PFA System also reduces exposure to radiation (fluoroscopy) during procedures and supports improved long-term patient safety.¹³

"Reducing the need for general anesthesia--without sacrificing outcomes--has been a clear priority for physicians performing PFA procedures. With its introduction in Canada, the Volt PFA System enables an approach that can support conscious sedation and may help make procedures more efficient while supporting quicker recovery." explains Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business.

Regulatory Authorization in Canada and Global Availability

The Volt PFA System received Health Canada authorization in April 2026. The system is also approved and available in the United States, Europe and Australia.

For important safety information on Volt PFA System, visit: https://manuals.eifu.abbott/en/index.html.

FIRST CANADIAN USE OF ABBOTT'S VOLT PFA SYSTEM ADVANCES MINIMALLY INVASIVE AFIB CAREAbout Abbott:

Abbott (NYSE: ABT) 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 122,000 colleagues serve people in more than 160 countries. Together with our foundation, Abbott Fund, we partner with trusted organizations to build programs that strengthen care, improve access and help families and communities thrive. We're committed to building a healthier future by inspiring lifelong habits that support well-being and help to prevent chronic disease for generations to come.

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

¹ Andrade J, et al. The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation. Canadian Journal of Cardiology. 2020;36:1847-1948. https://www.onlinecjc.ca/article/S0828-282X(20)30991-0/fulltext
² Atrial Fibrillation. Heart & Stroke. Accessed on June 22, 2026. Atrial fibrillation | Heart and Stroke Foundation
³ Health Canada. Regulatory Decision Summary - CURRENT PFA. https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-medical-device-detail.php?linkID=RDS16816
⁴ Verma A, et al. Balloon-in-Basket Pulsed Field Ablation for Pulmonary Vein Isolation: 1-Year Outcomes of the VOLT-AF IDE Study. JACC Clin Electrophysiol. 2026;12(6):1287-1299.
⁵ Rivera A, et al. Adjunctive low-voltage area ablation for patients with atrial fibrillation: An updated meta-analysis of Randomized Controlled Trials. Journal of Cardiovascular Electrophysiology. 2024;35(7):1329-1339.
⁶ Huo Y, et al. Low-Voltage Myocardium-Guided Ablation Trial of Persistent Atrial Fibrillation. NEJM Evid. 2022;1(11):EVIDoa2200141.
⁷ Tilz, RR et al. (2025, January 17) Acute results demonstrate the safety and effectiveness of the balloon-based pulsed field ablation system for de novo PVI in PAF and PersAF [Late Breaking Presentation]. AF Symposium 2025, Boston, MA, USA.
⁸ Tilz, R., et al. Long-Term Safety and Effectiveness of balloon-based PFA system for de novo PVI to treat PAF and PersAF: Results from the VOLT CE Mark Study [Oral presentation]. Presented by Prash Sanders. Heart Rhythm Society 2025, San Diego, CA.
⁹ Data on file 90985059.
¹⁰ Data on file 91104530.
¹¹ Tilz R, et al. Acute safety and procedural characteristics of conscious and deep sedation to general anesthesia workflows with novel balloon-based PFA system [Oral presentation and abstract]. EHRA 2025.
¹² Lo M, et al. Procedural efficiency, safety and acute effectiveness of conscious and deep sedation workflows with novel balloon-based PFA system [Poster presentation]. Heart Rhythm Society 2025, San Diego, CA.
¹³ Kuhne M, et al. Pulsed field ablation for the interventional treatment of atrial fibrillation: a scientific statement of the European Heart Rhythm Association of the European Society of Cardiology, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, the Latin American Heart Rhythm Society, and the Canadian Heart Rhythm Society. Europace. 2026;28(6): euag080.

SOURCE Abbott

Stacey Brown, 416 618-7490, [e-mail]