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Feb 9, 2026 8:01 AM

Johnson & Johnson Reports 90% AFib Freedom In Early Heart Device Study

Johnson & Johnson (NYSE:JNJ) on Friday after hours released data from the OMNY-AF pilot study, a prospective, single-arm, multi-center trial.

The study pairs the OMNYPULSE Catheter, a 12 mm large-tip focal catheter featuring contact-force sensing and bipolar, biphasic pulse delivery, with the TRUPULSE Generator.

The integrated design combines precise mapping, controlled energy delivery, and live feedback through the PF index on the CARTO 3 System.

The OMNYPULSE Platform is not currently approved in any region of the world.

The study reported a 90% 12-month freedom from AFib with zero procedure-related adverse events, which could be a significant development for the company’s cardiovascular treatment portfolio, even as broader markets experienced mixed performance.

OMNY-AF Study Shows 90% AFib Freedom

The OMNY-AF pilot study evaluated the investigational OMNYPULSE Platform for treating symptomatic paroxysmal atrial fibrillation (AFib) and showed 100% acute procedural success across a 30-patient cohort.

AFib is an irregular, often rapid heart rate that occurs in temporary episodes, starting ...

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