Johnson & Johnson Highlights Favorable 12-Month Interim Results for the VARIPULSE Platform at EHRA 2026

Irvine, CA - April 13, 2026 - Johnson & Johnson today announced favorable 12-month interim effectiveness and safety results from VARIPURE, the largest prospective post-market follow-up study evaluating first-time pulsed field ablation (PFA) using the VARIPULSE Platform. The data were presented at the PFA Summit during the 2026 European Heart Rhythm Association (EHRA) Annual Meeting in Paris and simultaneously published in Europace.

Key 12-month highlights include:

• High effectiveness with 84.2% freedom from all documented atrial arrhythmia recurrence at 12 months¹, including 90.5% for paroxysmal patients and 75.3% for persistent patients², based on Kaplan-Meier estimates.ⁱ
• A strong safety profile with 0.8% primary adverse event (PAE) rate and zero reported strokes, coronary spasm or other PFA-related complications.^i,3
• Complete cohort includes 1,023 patients across 22 European centers. At the time of analysis, 442 patients completed 12-month follow-up.
• 29.7% of patients were treated beyond the pulmonary veins⁴, demonstrating VARIPULSE Platform versatility.

"The VARIPURE results adds important real-world evidence demonstrating that pulsed field ablation with the VARIPULSE Platform can deliver both durable effectiveness and a consistently strong safety profile across a broad AFib populationi," said Daniel Scherr⁵, M.D., Department of Cardiology, Medical University of Graz, Austria. "What is particularly compelling is the combination of sustained 12-month outcomes and strong safety profile, which are critical indicators of long-term treatment success in everyday clinical practicei."

"VARIPURE represents a significant step forward in the evolution of pulsed field ablation, demonstrating strong results in a real-world clinical setting as VARIPULSE use expands. The observations in persistent AFib patients, along with meaningful experience outside pulmonary vein isolation, speak to the platform's versatility across a wide range of patient types and ablation strategiesi," said Gregory Michaud, M.D., Chief Medical and Scientific Officer, Electrophysiology, Johnson & Johnson. "A continuous commitment to rigorous evidence generation and deep scientific expertise will further elevate the standard of care for patients with AFib and complex arrhythmias."

The company also announced CE-mark approval to update the Instructions for Use (IFU) of the VARIPULSE Catheter to allow ablation outside the pulmonary veins in Europe, following DEKRA approval based on real-world data. The change also enables workflows for the treatment of patients with persistent AFib. This reflects the growing clinical evidence supporting the technology, marking continued regulatory progress in EMEA.

Johnson & Johnson continues to grow the body of research supporting its electrophysiology portfolio, accelerating the adoption of PFA in treating AFib. Findings presented at EHRA 2026, including VARIPURE, reflect data-driven advancements in clinical practice that enable physicians to deliver more effective and efficient care for patients with AFib.

About the VARIPURE Study
VARIPURE, a substudy of SECURE, is a prospective, observational, multicenter postmarket follow-up study in Europe designed to systematically assess the safety and performance of PFA using the VARIPULSE Platform in routine clinical practice. By having patients consent prior to the procedure, ensuring all patient data collection through electronic data capture, implicates a higher level of scientific quality compared to retrospective data collection. This approach includes meticulous monitoring and data cleaning, alongside diligent oversight of safety data collection and review, thereby ensuring the accuracy and integrity of the dataset. This rigorous upfront monitoring is absent in most published data from PFA registries to date.

About the VARIPULSE Platform
The VARIPULSE Platform is Johnson & Johnson MedTech's Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE Catheter, TRUPULSE Generator, and CARTO 3 Mapping System VARIPULSE Software.

Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit www.jnjmedtech.com.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at https://www.jnjmedtech.com. Follow us at @JNJMedTechand on LinkedIn.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to the VARIPULSE Platform. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

In the US, VARIPULSE™ Catheters are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.

© Johnson & Johnson and its affiliates 2026. All rights reserved. US_ELP_THER_41480

Footnotes
¹ Freedom from documented (symptomatic and asymptomatic) atrial arrythmia recurrence with episodes ≥30 seconds recorded by ECG after a 3-month blanking period

² VARIPULSE is approved in the U.S. for the treatment of paroxysmal patients only

³ Patients without at least 90 days of follow-up are excluded from the safety evaluation unless they experienced a PAE

⁴ VARIPULSE in the U.S. is not indicated to use outside the pulmonary veins

⁵ Dr. Scherr served as a study investigator and as a consultant for Johnson & Johnson. Dr. Scherr was not compensated for this authorship contribution.

ⁱ Scherr D, Bessière F, Kronborg MB, et al; VARIPURE Investigators. Effectiveness of AF pulsed field ablation with a variable loop circular catheter: 12-month VARIPURE results. Presented at: PFA Summit: European Heart Rhythm Association (EHRA) Congress; April 11, 2025; Paris, France.

Media Contacts:
Erin Farley
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Majo Echeverria
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