Johnson & Johnson (J&J) MedTech has announced positive initial three-month results from the Omny-IRE study evaluating the investigational Omnypulse platform in patients with paroxysmal atrial fibrillation (AF). The data, unveiled as a late-breaking presentation at the 2025 Heart Rhythm Society (HRS) annual meeting (24–27 April, San Diego, USA), demonstrated the potential for both high acute effectiveness and a promising safety profile—as per a 100% rate of acute pulmonary vein isolation (PVI) with durable isolation in 84.5% of pulmonary veins at three-month remapping and a 3% primary adverse event rate, with only 0.7% being potentially catheter related. The data have been simultaneously published in JACC: Clinical Electrophysiology.
Omny-IRE is a 12-month, prospective, multicentre, non-randomised clinical trial evaluating the safety and effectiveness of the Omnypulse platform for the mapping and treatment of symptomatic paroxysmal AF 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. J&J MedTech claims that the Omnypulse catheter is the first large-tip, 12mm focal catheter with contact force sensing and a TRUEref reference electrode intended to reduce the impact of far-field unipolar signals. The Trupulse generator provides a bipolar, biphasic pulse application to the catheter’s 12 electrodes.
With the Carto 3 system software used in the study, clinicians were able to obtain a PF index value for each ablation, which is a calculation using the real-time contact force feedback combined with the number of PF 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, according to J&J MedTech.
“The three-month data provide encouraging early evidence of the Omnypulse platform,” said Mattias Duytschaever (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 AF.”
New VARIPURE data
Data from the VARIPURE study were also shared at the HRS annual meeting, elucidating the real-world safety and operator learning curve associated with the use of J&J MedTech’s Varipulse PFA platform in PVI procedures for AF. Conducted across 13 European sites, the prospective, post-market study included 247 patients and 40 operators with varying levels of experience, including first-time users.
According to the company, no serious adverse events were reported, and no complications were linked to the platform, including zero neurovascular events or coronary spasms. Among a subset of 115 patients treated by operators performing their first 10 Varipulse cases, results showed no measurable learning curve beyond a modest reduction in idle time between ablations, underscoring the “efficiency and ease” of adopting this technology. VARIPURE is an ongoing registry with more than 600 patients enrolled to date.
“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. As adoption of PFA expands, I believe Varipulse can play a key role in broadening access to safe and streamlined ablation procedures,” said Francis Bessière (Hospices Civils de Lyon, Lyon, France).
Findings on dual-energy PFA catheter
Additional data presented at HRS 2025 by Hiroshi Nakagawa (Cleveland Clinic, Cleveland, USA) included a new preclinical validation of a PF index from the dual-energy Thermocool Smarttouch SF catheter, leveraging data from lesions created in a swine beating heart model.
The analysis confirmed that lesion depth—which, according to J&J MedTech, is crucial for effective treatment—correlates strongly with the number of PFA pulses and contact force using a logarithmic PF index, having accurately predicted lesion depth within ±1mm in 92% of cases and ±1.5mm in all cases. These findings reinforce the reliability of the pulse dosing protocol and underline the PF index’s value as a practical tool for guiding ablation, J&J MedTech claims. The index is specifically optimised to support durable lesion formation, offering physicians confidence in its outputs and enabling them to make informed, real-time decisions with a high degree of procedural predictability and clinical precision, the company’s release adds.
These new data follow the announcement of 12-month results from the SmartfIRE study, which were presented at the 2025 European Heart Rhythm Association (EHRA) congress (30 March–1 April, Vienna, Austria) and indicated positive effectiveness outcomes with the dual-energy Thermocool Smarttouch SF catheter.
“Our PFA portfolio is built around what matters most to physicians—durability, control, safety and efficiency,” said Jennifer Currin, vice president of scientific affairs at J&J MedTech. “The Omny-IRE, VARIPURE and dual-energy Thermocool Smarttouch SF catheter data demonstrate our commitment to delivering safe, effective and reliable PFA tools.”
