Johnson & Johnson MedTech today reported Johnson & Johnson MedTech Omnypulse results from 12-month pilot data evaluating its investigational Omnypulse platform for atrial fibrillation.
The Omnypulse platform includes the Omnypulse catheter and Trupulse generator, integrating with the Carto 3 mapping system to combine pulsed field ablation therapy and advanced cardiac mapping. Results from the OMNY-AF study, presented at the 31st Annual AF Symposium in Boston, covered a 30-patient pilot cohort across eight centres.
The findings showed 100% acute procedural success with no procedure-associated adverse events. More than half of cases were completed with zero fluoroscopy, and 90% of patients met the primary effectiveness endpoint at 12 months.
“The 12-month data provide encouraging early evidence on the OMNY-AF study with promising safety outcomes – no procedure-related adverse events or MRI-detected cerebral lesions – across eight centers in the pilot phase. In my cases during the ongoing OMNY-AF trial, the seamless integration of advanced mapping, ultrasound, and PF Index with contact force were valuable for precise and efficient pulsed field energy delivery,” said Dr. Dinesh Sharma, section head of cardiac electrophysiology at the Naples Heart Institute and the study’s presenting author.
Alongside Johnson & Johnson MedTech Omnypulse results, the company shared new safety data for its Varipulse pulsed field ablation platform. A study presented at the same meeting assessed neurovascular event rates following workflow enhancements and the introduction of an optimized irrigation flow rate.
Varipulse reported a 0.22% rate of neurovascular events among 6,811 patients after implementation of these updates. Further supporting data consisted of a physician questionnaire detailing 850 procedures which found low complication rates and no instances of coronary spasm or death. REAL AF registry also demonstrated low overall acute safety event rate with zero neurovascular events.
“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 Dr. Gregory Michaud, chief medical and scientific officer, Electrophysiology, Johnson & Johnson 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.”