OmnyPulse: Promising AFib Solution
Johnson & Johnson MedTech, announced positive, initial 3-month results from the Omny-IRE study, evaluating the investigational Omnypulse Platform in patients with paroxysmal atrial fibrillation (PAF).
The data, unveiled as a late breaking presentation at the 2025 Heart Rhythm Society (HRS) annual meeting, demonstrated the potential for both high acute effectiveness and a promising safety profile: 100% acute PVI with durable isolation in 84.5% of pulmonary veins at 3-month remapping and a 3.0% primary adverse event rate, with only 0.7% being potentially catheter related. The data has been simultaneously published in JACC Clin Electrophysiology (see citation below).
Omny-IRE is a 12-month prospective, multi-center, non-randomized clinical trial that evaluates the safety and effectiveness of the Omnypulse Platform for the mapping and treatment of symptomatic PAF during standard ablation procedures. The Omnypulse Platform consists of the Omnypulse Catheter, a novel focal pulsed field ablation (PFA) catheter, and the Trupulse Generator, and is fully integrated with the CARTO 3 System. The OMNYPULSE Catheter is the first large-tip, 12 mm focal catheter with contact force sensing and a TRUEref reference electrode to reduce the impact of far-field unipolar signals. The Trupulse Generator provides a bipolar, biphasic pulse application to the catheter’s twelve electrodes. With the CARTO 3 System software used in the study, clinicians were able to obtain a Pulsed Field (PF) Index value for each ablation, which is a calculation using the real-time contact force feedback combined with the number of pulsed field applications. As an integrated platform, Omnypulse brings together mapping precision, energy delivery, and real-time feedback into a single ecosystem—streamlining workflows and helping electrophysiologists deliver more consistent outcomes.
“The 3-month data provide encouraging early evidence of the Omnypulse Platform,” said Mattias Duytschaever M.D., Ph.D., Department of Cardiology, Electrophysiology Section, AZ Sint-Jan Hospital, Brugge, Belgium. “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.”
Citation: PVI With CF-Sensing Large-Tip Focal PFA Catheter With 3D-Mapping for Paroxysmal AF: Omny-IRE 3-Month Results. Authors: Mattias Duytschaever, Massimo Grimaldi, Tom De Potter, Atul Verma et al. J Am Coll Cardiol EP. Apr 25, 2025. Epublished DOI: 10.1016/j.jacep.2025.04.008
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