Johnson & Johnson Reveals Promising Results of VARIPURE Substudy on VARIPULSE™ Platform at ESC 2025

Insights from the VARIPURE Substudy at the ESC 2025

Johnson & Johnson MedTech, a frontrunner in cardiac arrhythmia innovations, has unveiled remarkable findings from the VARIPURE substudy, which evaluates the VARIPULSE™ Platform's performance in real-world settings. Presented at the prestigious European Society of Cardiology (ESC) Congress in Madrid, this substudy reports significant data on the safety and effectiveness of pulsed field ablation (PFA) in patients suffering from atrial fibrillation (AF).

According to the acute results shared, VARIPURE demonstrated a commendable safety profile with no reported strokes and a 99.7% success rate in acute pulmonary vein isolation (PVI) among 791 patients. The study shows that the platform achieves a low primary adverse event rate of just 0.6%, thus showcasing its efficacy and reliability in clinical settings.

The VARIPURE study is an observational, prospective, and multicenter post-market analysis conducted across 20 centers in Europe. With the involvement of 62 practicing operators, the study aimed to systematically assess the safety, effectiveness, and procedural characteristics of AF ablation procedures utilizing the VARIPULSE™ Platform. This platform comprises the VARIPULSE™ Catheter and TRUPULSE™ Generator, which seamlessly integrate with the CARTO™ 3 System, enhancing the procedural workflow and optimizing outcomes for AF patients.

Dr. Alexandre Almorad, the lead author and director at the Brussels Heart Rhythm Management Center, emphasized the importance of the study's findings. He stated, "The absence of strokes, coronary spasms, or other PFA-related complications signifies a favorable safety profile for the VARIPULSE™ Platform. The results observed across the varying procedural workflows reinforce the platform's adaptability and consistent applicability. With a 99.7% PVI rate and integration into diverse workflows, we have the foundation to inspire confidence in the safe adoption of PFA among electrophysiologists."

Furthermore, it's noteworthy that the VARIPURE study is backed by a higher standard of scientific quality due to its systematic data collection process. Patients consented prior to their procedures, and all data was collected using electronic capture methods. This meticulous approach ensures accuracy and mitigates some of the issues often faced in retrospective studies.

Johnson & Johnson MedTech continues its commitment to further enhancing the real-world evidence behind the VARIPULSE™ technology. Jennifer Currin, Vice President of Scientific Affairs in Electrophysiology, stated that the company is dedicated to collaborating with clinical professionals to gather robust clinical data. This is part of their wider goal of establishing a new standard of care in cardiac ablation treatments, ultimately advancing patient outcomes on global platforms.

In addition to the VARIPURE study revelations, data from the recent REAL AF Registry—another initiative by Johnson & Johnson—was also highlighted. Conducted across 70 sites in the United States and Canada, the REAL AF study engaged 200 diverse clinical profiles and demonstrated an impressive safety record without strokes or hospitalizations tied to the VARIPULSE™ Platform.

Johnson & Johnson's efforts in the cardiovascular space underline their commitment to addressing significant health challenges faced by patients globally. With innovations in heart rhythm disorder treatments and continuous research efforts, the company aims to improve clinical practices and patient care significantly in the near future.

The VARIPULSE™ Platform is presently approved in various regions, including the United States, Europe, Asia Pacific, Canada, and Latin America, and stands as a testament to Johnson & Johnson's leadership in the MedTech industry, continually striving to meet the needs of patients and healthcare providers alike.

In conclusion, the findings from both the VARIPURE substudy and the REAL AF Registry enhance the confidence in PFA as an effective treatment modality for atrial fibrillation, paving the way for improved patient care through innovative technology.