Johnson & Johnson MedTech announced positive initial results from the Omny-IRE clinical trial evaluating its investigational OMNYPULSE Platform for treating paroxysmal atrial fibrillation (PAF). The 3-month data, presented at the 2025 Heart Rhythm Society (HRS) annual meeting, demonstrated both high effectiveness and a promising safety profile for this novel pulsed field ablation (PFA) technology.
The study showed 100% acute pulmonary vein isolation (PVI) success with durable isolation maintained in 84.5% of pulmonary veins at the 3-month remapping. Safety outcomes were equally encouraging, with only a 3.0% primary adverse event rate, of which just 0.7% were potentially catheter-related. These findings were simultaneously published in JACC Clinical Electrophysiology.
"The 3-month data provide encouraging early evidence of the OMNYPULSE Platform," said Mattias Duytschaever, M.D., Ph.D., from the Department of Cardiology, Electrophysiology Section at AZ Sint-Jan Hospital in 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."
Innovative Technology Integration
The OMNYPULSE Platform represents a significant advancement in PFA technology. It integrates the OMNYPULSE Catheter—a novel focal PFA catheter with a large 12mm tip and contact force sensing—with the TRUPULSE Generator and the CARTO 3 System. This integration provides electrophysiologists with real-time feedback through a Pulsed Field (PF) Index, which calculates contact force combined with the number of pulsed field applications.
The system's design aims to streamline workflows while delivering consistent outcomes by bringing together mapping precision, energy delivery, and real-time feedback in a single ecosystem. This integrated approach addresses key challenges in atrial fibrillation treatment, potentially improving procedural efficiency and patient outcomes.
VARIPURE Registry Shows Strong Real-World Performance
Additional data from the VARIPURE registry presented at HRS evaluated the real-world safety and operator learning curve associated with the VARIPULSE Platform for PVI procedures. The prospective, post-market study included 247 patients across 13 European sites, with 40 operators of varying experience levels, including first-time users.
Notably, the registry reported no serious adverse events and no complications linked to the platform, including zero neurovascular events or coronary spasms. Among 115 patients treated by operators performing their first 10 VARIPULSE cases, results showed virtually no measurable learning curve beyond a modest reduction in idle time between ablations.
"The VARIPULSE Platform has both a strong safety profile and is highly accessible to new users, enabling safe and consistent outcomes from the very first case," noted Francis Bessière, M.D., Ph.D., from the Cardiac Electrophysiology Department at Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, France. "As adoption of PFA expands, I believe VARIPULSE can play a key role in broadening access to safe and streamlined ablation procedures."
The VARIPURE registry continues to enroll patients, with over 600 participants to date.
Preclinical Validation of Dual Energy Technology
Dr. Hiroshi Nakagawa presented new preclinical validation data for the PF Index from the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter. Using lesions created in a swine beating heart model, the analysis confirmed that lesion depth correlates strongly with the number of PFA pulses and contact force using a logarithmic PF Index.
The index accurately predicted lesion depth within ±1 mm in 92% of cases and within ±1.5 mm in all cases. These findings validate the reliability of the pulse dosing protocol and highlight the PF Index's value as a practical tool for guiding ablation with high procedural predictability and clinical precision.
Expanding PFA Portfolio
These multiplatform findings advance the clinical and technical validation of Johnson & Johnson MedTech's PFA portfolio across focal, regional, and dual energy catheter designs—each leveraging CARTO 3 System integration and real-time lesion feedback.
"Our PFA portfolio is built around what matters most to physicians—durability, control, safety, and efficiency," said Jennifer Currin, Ph.D., Vice President of Scientific Affairs at Johnson & Johnson MedTech. "The Omny-IRE, VARIPURE, and Dual Energy THERMOCOOL SMARTTOUCH SF Catheter data demonstrate our commitment to delivering safe, effective, and reliable PFA tools."
About the Omny-IRE Study
Omny-IRE is a 12-month prospective, multi-center, non-randomized clinical trial evaluating the safety and effectiveness of the OMNYPULSE Platform for mapping and treating symptomatic PAF during standard ablation procedures. The study is being conducted in Europe and Canada to demonstrate the platform's capabilities while also assessing the incidence of primary adverse events within seven days post-procedure.
The OMNYPULSE Platform is not currently approved in any region of the world, while the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter received European CE Mark in December 2024 but remains investigational in the United States.
These latest developments build on Johnson & Johnson MedTech's broader commitment to advancing PFA technology, including the recently announced 12-month results from the SmartfIRE clinical trial presented in March 2025.
