Johnson & Johnson MedTech (J&J MedTech) stated that the investigational OMNYPULSE Platform achieved 100% acute success and 84.5% pulmonary vein isolation (PVI) durability at three months, as per the data from the Omny-IRE study.
These results were presented at the 2025 Heart Rhythm Society Annual Meeting, reflecting significant advancements in managing paroxysmal atrial fibrillation (PAF). The study also reported a primary adverse event rate of 3.0%, with only 0.7% potentially related to the catheter.
The investigational OMNYPULSE Platform employs pulsed electrical field energy to create intracardiac lesions for atrial fibrillation treatment. It comprises the TRUPULSE Generator and OMNYPULSE Catheter, functioning in conjunction with the CARTO 3 System. While not yet approved globally, the platform is under evaluation in Europe and Canada as part of the Omny-IRE trial, which seeks to verify its safety and efficacy.
The Omny-IRE study is a 12-month, multi-centre trial designed to evaluate the safety and effectiveness of the OMNYPULSE Platform. This system includes the OMNYPULSE Catheter and TRUPULSE Generator and is fully integrated with the CARTO 3 System.
OMNYPULSE aims to enhance mapping precision and real-time feedback during standard ablation procedures for symptomatic PAF.
Mattias Duytschaever from AZ Sint-Jan Hospital in Belgium said: “The 3-month data provide encouraging early evidence of the OMNYPULSE Platform. What’s most compelling is the combination of 100% acute and strong remap success with a low rate of safety events.
“These results reinforce the potential of OMNYPULSE and its integration with the CARTO 3 System to deliver reproducible, durable outcomes for patients with paroxysmal AFib.”
In addition, the VARIPURE study’s findings were presented by Johnson & Johnson MedTech, exploring real-world safety and the learning curve associated with the VARIPULSE Platform in atrial fibrillation procedures.
Conducted across 13 European sites with 247 patients and 40 operators, the study observed no serious adverse events, validating the platform’s safety and operational efficiency. Among 115 patients treated by first-time VARIPULSE users, the study noted minimal learning curve requirements, suggesting ease of adoption.
Further data by Dr Hiroshi Nakagawa provided preclinical validation using a swine heart model, demonstrating a correlation between lesion depth and pulsed field ablation (PFA) pulses, thereby supporting procedural predictability and precision.
These findings contribute to the wider validation of Johnson & Johnson MedTech’s PFA portfolio, which includes focal, regional, and dual energy catheter designs.
