Johnson & Johnson’s OMNYPULSE Pilot Shows 90% AFib Freedom and Zero Adverse Events
Johnson & Johnson’s OMNY-AF pilot study of the investigational OMNYPULSE Platform reported 90% 12-month freedom from atrial fibrillation and zero procedure-related adverse events across a 30-patient cohort. The study also showed 100% acute procedural success, 56.7% zero-fluoroscopy cases and a 0.22% neurovascular event rate on the VARIPULSE platform.
1. OMNY-AF Study Results
Johnson & Johnson’s prospective, single-arm OMNY-AF pilot evaluated the investigational OMNYPULSE Platform in 30 patients with symptomatic paroxysmal atrial fibrillation and achieved 100% acute procedural success, 90% freedom from AFib at 12 months and zero procedure-related adverse events.
2. Platform Technology Details
The OMNYPULSE system pairs a 12 mm large-tip focal catheter with contact-force sensing and bipolar, biphasic pulse delivery via the TRUPULSE Generator, integrating mapping, controlled energy output and real-time feedback through the PF index on the CARTO 3 System.
3. Safety and Efficiency Metrics
Over half of procedures (56.7%) were completed without fluoroscopy, highlighting reduced radiation exposure, and earlier VARIPULSE platform data showed a 0.22% neurovascular event rate among 6,811 patients, underscoring the device’s favorable safety profile.
4. Market and Analyst Outlook
While the OMNYPULSE Platform remains unapproved globally, positive pilot data could bolster Johnson & Johnson’s cardiovascular portfolio, with analysts maintaining a Buy consensus and raising price targets to as high as $262 based on growth expectations.