Johnson & Johnson MedTech Shares Promising 3-Month Results from Omny-IRE Trial at HRS 2025

Johnson & Johnson MedTech Presents Positive Three-Month Results from Omny-IRE Study at 2025 Heart Rhythm Society Meeting

At the 2025 Heart Rhythm Society (HRS) annual meeting held on April 25, Johnson & Johnson MedTech announced encouraging findings from its groundbreaking Omny-IRE clinical trial which measures the effectiveness of the investigational OMNYPULSE™ Platform in patients suffering from paroxysmal atrial fibrillation (PAF). These findings mark a significant milestone in cardiac care, with early data highlighting both impressive efficacy and safety outcomes.

The trial revealed a remarkable 100% acute success rate in pulmonary vein isolation (PVI), along with an 84.5% durability of this isolation after three months. The trial also reported a minimal primary adverse event rate of just 3.0%, of which only 0.7% were likely related to the catheter itself. These statistics provide a strong basis for the OMNYPULSE™ Platform’s potential to transform treatment protocols for patients affected by this serious cardiac condition.

Built around the cutting-edge OMNYPULSE™ Catheter and the TRUPULSE™ Generator, the OMNYPULSE™ Platform represents a sophisticated approach to cardiac ablation. The catheter is the first of its kind to employ focal pulsed field ablation and offers a unique reference electrode to minimize far-field interference. The integration with the CARTO™ 3 System enhances clinicians’ ability to achieve precise energy delivery while ensuring real-time feedback that is vital for effective treatments. This integrated system not only improves the operator experience but also helps standardize outcomes across diverse patient demographics.

Dr. Mattias Duytschaever from AZ Sint-Jan Hospital in Belgium presented these findings at the conference and emphasized the importance of combining high levels of efficacy with a solid safety profile. He stated, "What's most compelling is the combination of 100% acute and strong remap success with a low rate of safety events. These results strengthen the promise of OMNYPULSE and its integration with the CARTO™ 3 System."

In conjunction with the Omny-IRE results, Johnson & Johnson also highlighted data from the VARIPURE registry, a study investigating the learning curve and safety profile associated with the VARIPULSE™ Platform used for pulmonary vein isolation. Conducted across 13 sites in Europe, this post-market study showcased the safety and user-friendly nature of its innovative heart-health technology, reinforcing its effectiveness even among operators with minimal experience. No serious adverse events occurred throughout the study, affirming the VARIPULSE™ Platform's reliability.

Furthermore, new preclinical insights were shared regarding the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter's efficacy. These findings, illustrated through a swine model, validated the correlation between lesion depth and the number of pulsed field applications, crucial for achieving optimal treatment in atrial fibrillation patients.

Dr. Hiroshi Nakagawa, who presented this crucial data, asserted that consistent input, like that provided through the PF Index, fosters accurate clinical decision-making during procedural execution. The ongoing evolution of these technologies holds substantial promise for advancing clinical practices in cardiac care.

Collectively, these findings from the Omny-IRE study, the VARIPURE registry, and the Dual Energy THERMOCOOL study reflect Johnson & Johnson MedTech's unwavering commitment to innovation in cardiac arrhythmia treatment. With a strategic focus on durability, control, safety, and efficiency, the development of the PFA portfolio positions the company as a crucial player in the fight against atrial fibrillation and other heart conditions.

For further information on Johnson & Johnson MedTech's advancements, the research presented at HRS is detailed on their official channels. This ambitious program demonstrates that through rigorous clinical studies and ground-breaking technologies, Johnson & Johnson is paving the way for more effective treatments that address significant health challenges.