Johnson & Johnson Unveils Results from the VARIPURE Substudy of SECURE, a AG真人官方-World Study on VARIPULSE鈩� Platform, at 2025 European Society of Cardiology (ESC) Congress
Johnson & Johnson (NYSE:JNJ) has announced significant results from the VARIPURE substudy of SECURE, evaluating their VARIPULSE鈩� Platform for atrial fibrillation treatment. The study, conducted across 20 European centers with 791 patients, demonstrated remarkable safety and effectiveness metrics.
Key findings include a 0.6% primary adverse event rate with no strokes reported, and a 99.7% acute effectiveness rate in pulmonary vein isolation (PVI). The study involved 62 operators and evaluated acute safety, effectiveness, and procedural characteristics of index AF ablations. Additional supporting data from the REAL AF Registry across 70 US and Canadian sites showed no strokes, deaths, or device-related hospitalizations in 200 diverse clinical profiles.
Johnson & Johnson (NYSE:JNJ) ha reso noti risultati significativi dal sottostudio VARIPURE di SECURE, che valuta la loro piattaforma VARIPULSE鈩� per il trattamento della fibrillazione atriale. Lo studio, condotto in 20 centri europei su 791 pazienti, ha mostrato indicatori di sicurezza ed efficacia notevoli.
I risultati principali includono un tasso di eventi avversi primari dello 0,6% senza ictus segnalati e un tasso di efficacia acuta del 99,7% nell鈥檌solamento delle vene polmonari (PVI). Lo studio ha coinvolto 62 operatori e ha valutato sicurezza acuta, efficacia e caratteristiche procedurali nelle ablazioni indicizzate per FA. Dati di supporto aggiuntivi dal REAL AF Registry, raccolti in 70 siti tra Stati Uniti e Canada, hanno riportato assenza di ictus, decessi o ricoveri correlati al dispositivo in 200 profili clinici diversi.
Johnson & Johnson (NYSE:JNJ) ha anunciado resultados relevantes del subestudio VARIPURE de SECURE, que eval煤a su plataforma VARIPULSE鈩� para el tratamiento de la fibrilaci贸n auricular. El estudio, realizado en 20 centros europeos con 791 pacientes, mostr贸 m茅tricas destacadas de seguridad y eficacia.
Los hallazgos clave incluyen una tasa de eventos adversos primarios del 0,6% sin ictus reportados y una tasa de efectividad aguda del 99,7% en el aislamiento de las venas pulmonares (PVI). El estudio involucr贸 a 62 operadores y evalu贸 la seguridad aguda, la eficacia y las caracter铆sticas procedimentales de las ablaciones indexadas por FA. Datos complementarios del REAL AF Registry, en 70 centros de EE. UU. y Canad谩, no registraron ictus, muertes ni hospitalizaciones relacionadas con el dispositivo en 200 perfiles cl铆nicos diversos.
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欤检殧 瓴瓣臣搿滊姅 雵岇「欷� 氤搓碃 鞐嗢澊 0.6%鞚� 1彀� 鞚挫儊氚橃潙 氚滌儩毳�鞚� 氤挫榾瓿�, 韽愳爼毵� 瓴╇Μ(PVI)鞐愳劀電� 99.7%鞚� 旮夓劚 鞙犿毃毳�鞚� 旮半頄堨姷雼堧嫟. 鞐瓣惮鞐愲姅 62氇呾潣 鞁滌垹鞛愱皜 彀胳棳頄堨溂氅�, 旮夓劚 鞎堨爠靹�, 鞙犿毃靹� 氚� 歆�響滌劚 AF 鞝堨牅 鞁滌垹鞚� 鞝堨皑鞝� 韸轨劚鞚� 韽夑皜頄堨姷雼堧嫟. 氙嘎缝簮雮橂嫟 70臧� 旮瓣磤鞚� 韽暔頃� REAL AF Registry鞚� 於旉皜 歆�鞗� 雿办澊韯办棎靹滊姅 200臧滌潣 雼れ枒頃� 鞛勳儊 頂勲頃勳棎靹� 雵岇「欷�, 靷 霕愲姅 旮瓣赴 甏�霠� 鞛呾洂鞚� 鞐嗢棃鞀惦媹雼�.
Johnson & Johnson (NYSE:JNJ) a annonc茅 des r茅sultats importants du sous-茅tude VARIPURE de SECURE, 茅valuant leur plateforme VARIPULSE鈩� pour le traitement de la fibrillation atriale. L'茅tude, men茅e dans 20 centres europ茅ens aupr猫s de 791 patients, a montr茅 des indicateurs de s茅curit茅 et d'efficacit茅 remarquables.
Les principaux r茅sultats comprennent un taux d'茅v茅nements ind茅sirables primaires de 0,6% sans AVC rapport茅s, et un taux d'efficacit茅 aigu毛 de 99,7% pour l'isolation des veines pulmonaires (PVI). L'茅tude a impliqu茅 62 op茅rateurs et a 茅valu茅 la s茅curit茅 aigu毛, l'efficacit茅 et les caract茅ristiques proc茅durales des ablations AF index. Des donn茅es compl茅mentaires du REAL AF Registry, couvrant 70 sites aux 脡tats-Unis et au Canada, n'ont fait 茅tat d'aucun AVC, d茅c猫s ou hospitalisation li茅e au dispositif chez 200 profils cliniques vari茅s.
Johnson & Johnson (NYSE:JNJ) hat bedeutende Ergebnisse der VARIPURE-Unterstudie von SECURE bekannt gegeben, die ihre 痴础搁滨笔鲍尝厂贰鈩�-笔濒补迟迟蹿辞谤尘 zur Behandlung von Vorhofflimmern bewertet. Die Studie, durchgef眉hrt an 20 europ盲ischen Zentren mit 791 Patienten, zeigte bemerkenswerte Sicherheits- und Wirksamkeitswerte.
Zentrale Befunde sind eine 0,6%ige Rate prim盲rer unerw眉nschter Ereignisse ohne gemeldete Schlaganf盲lle sowie eine akute Wirksamkeitsrate von 99,7% bei der Isolation der Lungenvenen (PVI). An der Studie waren 62 Operateure beteiligt; untersucht wurden akute Sicherheit, Wirksamkeit und prozedurale Merkmale von Index-AF-Ablationen. Unterst眉tzende Daten aus dem REAL AF Registry an 70 Standorten in den USA und Kanada zeigten bei 200 unterschiedlichen klinischen Profilen keine Schlaganf盲lle, Todesf盲lle oder ger盲tebedingten Krankenhausaufenthalte.
- Exceptional safety profile with 0.6% primary adverse event rate and no strokes reported
- High effectiveness rate of 99.7% in pulmonary vein isolation procedures
- Successful implementation across 20 European centers, demonstrating broad clinical adaptability
- Strong validation from REAL AF Registry with no major adverse events in 200 additional cases
- None.
Insights
J&J's VARIPULSE Platform demonstrates exceptional safety (0.6% adverse rate, zero strokes) and 99.7% effectiveness in large real-world AF ablation study.
The VARIPURE substudy results represent a significant advancement in atrial fibrillation treatment technology. With 791 patients across 20 European centers and 62 operators, this real-world data carries substantial statistical weight. The 0.6% primary adverse event rate with no strokes is remarkably low for cardiac ablation procedures, where stroke risk typically remains a primary concern. The 99.7% acute pulmonary vein isolation (PVI) effectiveness rate further demonstrates the platform's exceptional clinical performance.
What makes these results particularly valuable is their demonstration of consistent outcomes across diverse procedural workflows, suggesting the VARIPULSE Platform offers reliable performance regardless of operator technique variations. This adaptability is crucial for widespread clinical adoption. The complementary REAL AF Registry data showing similar safety outcomes (no strokes, deaths, or device-related hospitalizations) in 200 North American patients reinforces the platform's safety profile across different patient populations and healthcare systems.
For context, pulsed field ablation represents a significant evolution in AF treatment compared to traditional radiofrequency or cryoablation approaches, potentially offering enhanced safety through tissue-selective ablation that reduces collateral damage to surrounding structures. J&J's integrated platform approach鈥攃ombining the VARIPULSE Catheter, TRUPULSE Generator, and CARTO 3 System鈥攁ppears to be delivering on this promise while maintaining workflow efficiency, a critical factor for electrophysiology lab adoption and procedure economics.
VARIPURE demonstrated strong safety outcomes with no incidence of stroke and
VARIPURE, a SECURE substudy, is a prospective, observational, post-market study conducted across 20 European centers, including 62 operators, that evaluated acute safety, effectiveness, and procedural characteristics of index AF ablations performed with the VARIPULSE鈩� Platform.i听The VARIPULSE鈩� Platform consists of the VARIPULSE鈩� Catheter and TRUPULSE鈩� Generator, which seamlessly integrates with the CARTO鈩� 3 System and enables an efficient and reproducible workflow that enhances treatment and optimizes outcomes for AF.ii,iii,iv
"An overall 0.6 percent primary adverse event rate with no strokes, coronary spasm, or other PFA-related complications demonstrates a favorable safety profile when using the VARIPULSE鈩⑻齈latform. These outcomes, observed in nearly 800 patients across varying procedural workflows, demonstrate the platform's consistent application and adaptability in this study. By delivering听a 99.7 percent acute PVI rate alongside seamless integration into diverse procedural workflows, this study reinforces our ability to deliver durable lesion sets, giving electrophysiologists the confidence to adopt PFA widely and safelyi," said Alexandre Almorad1, M.D., Cardiac听Electrophysiologist, Director of the Arrhythmia Unit at Brussels University Hospital St Pierre and at the Brussels Heart Rhythm Management Center, the study presenting author.
The consistency and scale of these results reinforce PFA as a transformative option for AF care, illustrating how the VARIPULSE鈩� Platform's safety, efficacy, and reproducibility are already reshaping everyday clinical practice.
1 | Dr. Almorad serves as a consultant for Johnson & Johnson but was not compensated for this announcement | ||||
In addition to VARIPURE, Johnson & Johnson MedTech recently highlighted at Kansas City HRS new real-world evidence regarding the VARIPULSE鈩� Platform from the company funded REAL AF Registry鈥攁 collaboration across 70 sites in the US and
"Johnson & Johnson MedTech is committed to advancing the real-world evidence base for VARIPULSE鈩�, generating robust clinical data to demonstrate its safety and efficacy across diverse patient populations," said Jennifer Currin,听Ph.D., Vice President, Scientific Affairs,听Electrophysiology, Johnson & Johnson MedTech. "Through growing registries and collaborative studies with electrophysiologists in everyday practice settings, we're building the clinical foundation that empowers physicians to optimize patient outcomes听and establish a new standard of care in cardiac ablation."
Johnson & Johnson MedTech will continue collaborating with the clinical community to expand real-world evidence around the VARIPULSE鈩� Platform and accelerate patient-centered innovation in atrial fibrillation care.
About the VARIPURE Study
VARIPURE, a substudy of SECURE, is a prospective, observational, multicenter postmarket follow-up study in
About the VARIPULSE鈩� Platform
The VARIPULSE鈩� Platform is Johnson & Johnson MedTech's Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE鈩� Catheter, TRUPULSE鈩� Generator, and CARTO鈩� 3 Mapping System VARIPULSE鈩� Software. The Platform is now approved for use in
Cardiovascular Solutions from Johnson & Johnson MedTech听
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 .
About Johnson & Johnson
At听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 . Follow us at听听and on听.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the VARIPULSE鈩� 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: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; 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 of purchasers of health care products and services; changes to applicable laws and regulations, including 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 , 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.听听
Important information
Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
This press release reports the use of VARIPULSE鈩� Catheter with 30mL/Min irrigation flow rate. In EU, the approval of this workflow is in review, it is not CE marked and not approved for use. Refer to the IFU applicable for your country for approved flow rate.
漏听Johnson & Johnson听and its affiliates 2025. All rights reserved. M_US_ELP_THER_405279
i Almorad A, Sebag FS, Brix Kronborg M, et al. Acute safety, effectiveness and procedural workflow for the pulsed field ablation variable loop circular catheter in AF procedures: a prospective, multicenter, post-market clinical trial. Presented at: European Society of Cardiology (ESC) Congress; September 1, 2025; | ||||
ii Di Biase L, Marazzato J, Gomez T, et al. Application Repetition and Electrode-Tissue-Contact Results in Deeper Lesions Using a Pulsed-Field Ablation Circular Variable Loop Catheter. Europace. Published online August听16, 2024. Page 3, paragraph 2, Results Section | ||||
iii 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. Page 5, Column 1, paragraph 1 | ||||
iv听Reddy VY, Calkins H, Mansour M, et al. Pulsed field ablation to treat paroxysmal atrial fibrillation: safety and effectiveness in the admIRE pivotal trial. Circulation. Published online September 11, 2024. doi: 10.1161/CIRCULATIONAHA.124.070333.Page 5, paragraph 2, Procedural Data Section | ||||
v Porterfield C, Krishnan K, Saleem M, Steckman D, Ebinger M, Gampa A, et al. AG真人官方-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 ( | ||||
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FAQ
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