Johnson & Johnson Advances Pulsed Field Ablation Portfolio with the Launch of VARIPULSE Pro in Europe

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Key Terms

pulsed field ablation medical

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.

ce mark regulatory

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.

carto 3 system technical

An advanced cardiac mapping and navigation system used during heart rhythm procedures to create a detailed, real-time 3D map of the heart’s electrical activity and anatomy. It helps doctors locate the precise spots that cause abnormal rhythms and steer catheters during corrective procedures, much like a GPS for the heart; investors watch adoption and upgrades because they drive device sales, procedure volume, and hospital purchasing decisions.

intracardiac echocardiography medical

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.

atrial fibrillation medical

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.

postmarket follow-up study medical

A postmarket follow-up study is research conducted after a medical product begins selling to track how it performs in everyday use, focusing on safety, side effects, and long-term effectiveness. Think of it like a routine checkup once a product is out in the wild; results can reveal problems not seen in trials and may trigger label changes, additional testing, recalls, or extra costs, all of which can affect a company’s reputation and financial outlook for investors.

04/07/2026 - 08:00 AM

The VARIPULSE Pro Platform features a new pulse sequence designed to streamline procedures and enhance workflow efficiency^i,ii

VARIPULSE Pro to be featured at EHRA 2026 alongside VARIPURE 12-month interim data

IRVINE, Calif.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) today announced the launch of VARIPULSE Pro in Europe following CE Mark approval, further advancing its pulsed field ablation (PFA) portfolio. This new pulse sequence marks the next evolution of the VARIPULSE Platform and is designed to improve procedural efficiency^i,ii while reinforcing its established safetyⁱⁱⁱ and effectiveness^iv profile.

VARIPULSE Pro Catheter

VARIPULSE Pro introduces a new pulse sequence with a lower temperature profile^1,2,iand an ablation that is 5 times faster than the previous sequence^3,ii, while achieving equivalent lesions^4,v. Building on the proven precision^vi,viiand safety profileⁱⁱⁱ of the VARIPULSE platform, VARIPULSE Pro integrates seamlessly with the CARTO 3 System, utilizing advanced mapping capabilities, including tissue proximity indicators for precise lesion delivery^vi,vii. With initial cases performed under the VARIPURE multicenter, prospective, postmarket follow-up study, the company is committed to generate rigorous evidence through VARIPURE and additional clinical studies during the commercial phase of the launch.

“In our early experience, VARIPULSE Pro has been exceptionally smooth and easy to use,” said Tom De Potter⁵, M.D., Head of Electrophysiology and Associate Director of the Heart Center, OLV Hospital, Aalst, Belgium. “The speed is particularly striking and contributes to more efficient procedures without compromising precisionⁱⁱ. The integration with CARTO mapping and intracardiac echocardiography (ICE) facilitate accurate positioning and consistent lesion delivery⁴, contributing to a very positive procedural experience.”

“The introduction of VARIPULSE Pro in Europe reflects our commitment to advancing our PFA platforms through continuous innovation, enhancing procedural experience while maintaining the consistency and precision physicians expect from the VARIPULSE Platform,” said Michael Bodner, Company Group Chair, Electrophysiology & Neurovascular, MedTech, Johnson & Johnson. “This launch demonstrates our dedication to continuously evolving PFA technologies based on real-world learnings and our scientific expertise, supporting physicians to deliver high-quality care and improved patient outcomes.”

The company will feature the VARIPULSE Pro Platform at the European Heart Rhythm Association (EHRA) annual meeting, including live case demonstrations, hands-on training sessions, and professional education. In addition, 12-month interim results from the ongoing VARIPURE study evaluating pulsed field ablation with the VARIPULSE Platform will be presented at the EHRA PFA Summit by Dr. Daniel Scherr⁶. For more information on Johnson & Johnson’s activities at EHRA 2026, visit here.

This milestone underscores Johnson & Johnson’s focus on innovation grounded in scientific expertise and real-world experience. With atrial fibrillation being the most common cardiac arrhythmia affecting more than 50 million people worldwide^viii and continuing to grow in prevalence, the company is leading the science and championing the evolution of PFA.

VARIPULSE Pro is not currently approved in the United States.

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 this website.

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 @JNJMedTech and 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 VARIPULSE Pro. 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: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; 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.

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¹ Compared to current VARIPULSE

² When compared to other competitive PF devices

³ When compared to first version of VARIPULSE

⁴ In preclinical testing

⁵ Dr. De Potter is a consultant for Johnson & Johnson. Dr. De Potter was not compensated for this authorship contribution.

⁶ Dr. Scherr served as a study investigator and as a consultant for Johnson & Johnson. Dr. Scherr was not compensated for this authorship contribution.

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ⁱ Zito E, Mansour M, Reddy VY, et al. Assessment of temperature dynamics in pulsed field ablation with a variable-loop circular catheter: a comparative analysis of waveform configurations and irrigation rates in specimens of bovine ventricular myocardium. Europace. 2025;27:euaf278. doi:10.1093/europace/euaf278.

ⁱⁱ VARIPULSE Pulse Field Ablations in an in vitro model: temperature characterization of sequence 2 at 30 mL/min vs commercial sequence 1 at 4 mL/min and 30 mL/min. Engineering report. Report No. 502270676.

ⁱⁱⁱ Almorad A, Vetta G, Della Rocca DG, et al. Real-world experience of atrial fibrillation ablation using a variable-loop circular catheter: a single-centre study. Europace. 2025;27(Suppl 1):i291.

^iv Porterfield C, Krishnan K, Saleem M, Steckman D, Ebinger M, Gampa A, et al. Real-world safety profile of a multi-electrode variable loop pulsed-field ablation catheter. Presented at: Kansas City Heart Rhythm Symposium 2025; August 16 2025; Overland Park (Kansas City), KS.

^v Di Biase L, Hsu J, Bhardwaj R, et al. Effect of pulsed field timing sequence and electrode cooling on ablation safety and efficacy surrogates: a preclinical study. Manuscript submitted for publication. 2026.

^vi Di Biase L, Marazzato J, Gomez T, et al. Application repetition and electrode-tissue contact result in deeper lesions using a pulsed-field ablation circular variable loop catheter. Europace. 2024;26(9):euae220. doi:10.1093/europace/euae220.

^vii Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023 Mar;16(3):e011780.

^viii Mensah, G, Fuster, V, Murray, C. et al. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec, 82 (25) 2350–2473.