- OMNY-AF study achieved 100% acute procedural success with no adverse events.
- 56.7% of cases used zero fluoroscopy, and 90% of patients met primary effectiveness at 12 months.
- VARIPULSE Platform showed a 0.22% neurovascular event rate in 6,811 patients.
- VARISURE survey reported a 1.9% primary adverse event rate in 850 procedures.
OMNY-AF Study Results
Johnson & Johnson presented 12-month pilot-phase data from the OMNY-AF study at the 31st Annual AF Symposium. The study evaluated the investigational OMNYPULSE Platform for treating symptomatic paroxysmal atrial fibrillation. Results showed 100% acute procedural success with no procedure-associated adverse events. Additionally, 56.7% of cases were performed without fluoroscopy, and 90% of patients achieved primary effectiveness at 12 months.
Study Design and Technology
OMNY-AF is a prospective, single-arm, multi-center clinical trial conducted across over 40 sites in the U.S. and Australia. The study uses the OMNYPULSE Catheter, featuring contact-force sensing and bipolar, biphasic pulse delivery, paired with the TRUPULSE Generator. This design integrates precise mapping, controlled energy delivery, and live feedback through the PF index on the CARTO 3 System.
VARIPULSE Platform Findings
Alongside OMNY-AF data, Johnson & Johnson highlighted findings related to the VARIPULSE Platform. Data showed a low neurovascular event rate of 0.22% in 6,811 patients after workflow enhancements and optimized irrigation flow rate. Additional data from the VARISURE Safety survey indicated a 1.9% rate of primary adverse events in 850 procedures, with a 0.2% incidence of neurovascular events and no coronary spasm or death reported.
Research and Safety
Research on irrigation flow optimization demonstrated parity between different irrigation rates in microbubble generation, hemolysis, and lesion depth, while confirming that higher irrigation reduced electrode surface heating. These findings reinforce the safety and consistency of Johnson & Johnson's electrophysiology portfolio.
