Johnson & Johnson (J&J) has announced 12-month pilot-phase data from the OMNY-AF study evaluating its investigational Omnypulse platform for the treatment of symptomatic paroxysmal atrial fibrillation (AF) during the 2026 AF symposium (5–7 February, Boston, USA). Initial outcomes across the 30-patient pilot cohort showed a 100% rate of acute procedural success with no procedure-associated adverse events, while 56.7% of cases were performed with zero fluoroscopy and 90% of patients achieved the study’s primary effectiveness endpoint at 12 months, according to J&J.
“The 12-month data provide encouraging early evidence on the OMNY-AF study with promising safety outcomes—no procedure-related adverse events or MRI [magnetic resonance imaging]-detected cerebral lesions—across eight centres in the pilot phase,” said study presenting author Dinesh Sharma (Naples Heart Institute, Naples, USA). “In my cases during the ongoing OMNY-AF trial, the seamless integration of advanced mapping, ultrasound and PF [pulsed-field] index with contact force were valuable for precise and efficient pulsed field energy delivery.”
OMNY-AF is a prospective, single-arm, multicentre clinical trial conducted across more than 40 sites in the USA and Australia. The study pairs the Omnypulse catheter, a 12mm large-tip focal catheter featuring contact force sensing and bipolar, biphasic pulse delivery, with J&J’s Trupulse generator. This integrated design combines precise mapping, controlled energy delivery and live feedback through the PF index on the Carto 3 system, the company claims. J&J also notes that the Omnypulse platform is not currently approved by regulators in any region of the world.
Alongside these OMNY-AF data, J&J has highlighted new findings related to its Varipulse pulsed field ablation (PFA) platform. Data presented by Andrea Natale (St David’s Medical Center, Austin, USA) and simultaneously published in JACC: Clinical Electrophysiology by Moussa Mansour (Heart and Vascular Institute, Boston, USA) et al examined the incidence of neurovascular events following workflow enhancements and the introduction of an optimised irrigation flow rate. The platform sustained a low neurovascular event rate of 0.22% across 6,811 patients after implementation of both workflow enhancements and the updated irrigation rate, according to J&J.
The company goes on to detail that additional Varipulse platform data presented at the AF symposium add to the growing body of evidence underscoring the platform’s consistent and favourable safety profile across a range of clinical and real-world settings.
J&J’s recent release highlights VARISURE safety survey data presented by Christopher Porterfield (Aurora Denver Cardiology Associates, Aurora, USA) as a notable example of this. Early results from this physician survey on 850 procedures indicated a low frequency of complications with a 1.9% rate of primary adverse events, a 0.2% incidence of neurovascular events, and no reported cases of coronary spasm or death. Same-day discharge was achieved in 87.9% of patients.
Additionally, a REAL AF registry analysis presented by Mohammad-Ali Jazayeri (Michigan Heart, Ann Arbor, USA) featured results showing excellent acute safety outcomes with the Varipulse catheter, as per a low overall acute safety event rate of 0.5% with no neurovascular events, high rates of same-day discharge, and no observed differences in safety outcomes across AF classifications.
The company also outlines irrigation flow optimisation research presented by Fengwei Zou (Montefiore Health System, New York, USA). Preclinical data demonstrated parity between the 4mL/min and 30mL/min irrigation rates in microbubble generation, haemolysis and lesion depth when using the Varipulse catheter while confirming that higher irrigation significantly reduced electrode surface heating.
“These data reinforce confidence in the consistency of safety outcomes observed across Johnson & Johnson’s electrophysiology portfolio. As a relatively new energy modality, pulse field ablation technologies should be individually evaluated for safety and reproducibility in atrial fibrillation ablation,” said Gregory Michaud, chief medical and scientific officer, electrophysiology, J&J MedTech. “As pulsed field ablation continues to evolve, rigorous evidence generation and transparent data sharing will be essential to advancing the science, and enabling the next wave of innovation with this technology.”
