Home VARIPULSE Demonstrates Zero Stroke Events and Near-Perfect Acute Pulmonary Vein Isolation Rate in Two Real-World Studies

VARIPULSE Demonstrates Zero Stroke Events and Near-Perfect Acute Pulmonary Vein Isolation Rate in Two Real-World Studies

Sep 02, 2025 22:16 CST Updated 22:16
Johnson & Johnson

Medical Device R&D and Manufacturer

Johnson & Johnson inESC2At the 025 ConferencePublicClothSECURE Study (VARIPURE Study)Subgroup)Results of Acute Safety and EffectivenessThe VARIPURE study is a research conducted in Europe20A real-world study conducted by the center to evaluate the VARIPULSE platform in atrial fibrillation pulmonary vein isolation (PVI) procedures.Real-world safety and operator learning curve.
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Johnson & JohnsonAnalysis of 791 patients shows:
The VARIPULSE platform boasts excellent safety, high acute effectiveness, and procedural efficiency, with a low incidence of major adverse events.0.6%And no stroke events occurred. Achieved at the same time99.7% Acute Pulmonary Vein Isolation Rate, and highly follows the recommended ablation workflow.
PI Evaluation
"Using the VARIPULSE platform, a major adverse event rate of only 0.6% was achieved, with no occurrence of stroke, coronary artery spasm, or other PFA-related complications, demonstrating its excellent safety. In studies involving nearly 800 patients using different surgical protocols, these results confirm the platform's consistent applicability and adaptability. By achieving a 99.7% acute pulmonary vein isolation rate and seamless integration with various procedural workflows, this study further validates our ability to deliver durable lesion sets, enabling electrophysiologists to apply PFA technology more broadly and safely."
---Alexandre Almorad   Brussels University Hospital St Pierre
Executive Evaluation
"Johnson & Johnson Medical Technologies is committed to advancing the real-world evidence base for VARIPULSE by generating robust clinical data to demonstrate its safety and efficacy in diverse patient populations. By continuously expanding registry studies and collaborative research with electrophysiologists in routine practice settings, we are building a solid clinical foundation that enables physicians to optimize patient outcomes and establish new standards in cardiac ablation therapy."
---Jennifer Currin  Vice President of Scientific Affairs, Electrophysiology, Johnson & Johnson Medical Technologies
In addition to the announcementIn addition to the VARIPURE study results, Johnson & Johnson is alsoAnnounced at the HRS 2025 ConferenceREAL AFRegistration Study (Another EvaluationReal-world study of the VARIPULSE platform conducted across 70 centers in the United States and Canada)。REAL AF analysis includes 200 cases treated with the VARIPULSE platform across different workflows, with nearly 80% of the procedures performed using a 30mL irrigation flow rate.
The study results showed no stroke, death, or device-related hospitalization events, with only one minor event deemed related to the surgical procedure (not the device).
From the research results published by Johnson & Johnson so farThe safety of the VARIPULSE platform is guaranteed, as demonstrated by two real-world studies.No stroke adverse events occurred on the VARIPULSE platform. Proving that as long as strictly in accordance withThe recommended ablation workflow will not occur at the beginning of the year.Neurovascular Events. Moreover, the study shows extremely low major adverse events (0.6%), confirmedVARIPULSE Platform High Security.


VARIPULSE
VARIPULSEConsisting of the VARIPULSE ablation catheter and TRUPULSE generator, and capable ofCompatible with Carto 3.VARIPULSEIs the first and only integratedCarto 3PFA Technology: Achieving an intuitive and reproducible workflow through real-time visualization and feedback mechanisms.Carto is Johnson & Johnson's greatest advantage in the PFA field to defeat other competitors in the future. Without3DLabelMeasurement SystemThe therapeutic effect of PFA is at least halved, while Johnson & Johnson possesses the most powerful and advanced technologies globally.3DMarkMeasurement System
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VARIPULSEThe ablation catheter was developed after Johnson & Johnson's previous mapping catheter, the LASSO catheter.Continuation of LASSO Catheter Technology. This also showcases Johnson & Johnson's expertise in the catheter field.Profound Technical Reserve

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VARIPULSEThe ablation catheter has 10 electrodes on its circular tip, and the size of the circular tip is adjustable (from 25 to 35mm). MeanwhileVARIPULSEThe ablation catheter allows for bidirectional deflection, with one side deflecting 180° and the other 90°, making it suitable for all four pulmonary veins, including the right inferior pulmonary vein. PFA is applied in a bipolar configuration between skipped electrodes (i.e., electrode 1 to electrode 3) as well as between each pair of adjacent electrodes (i.e., electrode 1-2 and 2-3), with an energy of 1800 V. Each PFA application consists of a sequence of microsecond-long biphasic pulses delivered across all three bipolar configurations, with a total application duration of approximately 250 milliseconds.

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Johnson & Johnson

Johnson & Johnson has always been committed to addressing the most complex health challenges globally. For a century, we have driven the advancement of surgical care through innovative products such as wound closure, hemostatic assistance, surgical stapling devices, robotics, and digital solutions. Collaborating with clinical experts worldwide, we continuously revolutionize surgical techniques to better meet patient needs in metabolic diseases, cardiovascular diseases, oncology, and plastic reconstruction.

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