European Investor
22 Oct 2026, 15:56
Johnson & Johnson Reports Strong VARIPULSE and OMNYPULSE Data in Atrial Fibrillation
Johnson & Johnson (NYSE: JNJ) reported new clinical data for two pulsed field ablation platforms at the APHRS 2026 meeting, highlighting strong acute procedural results for VARIPULSE Pro and encouraging 12-month outcomes for the investigational OMNYPULSE system.
In the VARIPURE study, which included 225 patients across 19 European centers, the VARIPULSE Pro Platform achieved 100% acute procedural success. The study reported one primary adverse event, representing a 0.4% rate, with no reported stroke, coronary spasm, acute kidney injury or death. Mean ablation time was 17.9 minutes, and a single-catheter mapping-and-ablation workflow was used in 88.9% of cases.
VARIPULSE Pro is currently available in Europe, Japan and certain other international markets, but is not approved in the United States.
Separately, the Omny-IRE study evaluated 136 patients with symptomatic paroxysmal atrial fibrillation. At 12 months, 82.5% of patients remained free from documented atrial fibrillation, atrial flutter or atrial tachycardia recurrence under stringent monitoring, rising to 90.1% under standard-of-care monitoring. The reported adverse-event rate was 2.9%, and all safety events were resolved.
Patients treated with OMNYPULSE also showed a 25.5-point mean improvement in the Atrial Fibrillation Effect on Quality-of-Life score, along with reductions in antiarrhythmic medication use and cardiovascular-related hospitalizations. OMNYPULSE remains investigational and is not approved or available for sale.
Johnson & Johnson also cited real-world database results suggesting lower long-term atrial-fibrillation-related acute-care utilization with its CARTO 3 mapping system compared with EnSite, with patients treated using EnSite showing a 31% higher risk of AF/AFL/AT-related inpatient readmission or emergency-room visits in that analysis.
The findings add clinical evidence across Johnson & Johnson’s electrophysiology portfolio and support the company’s broader push into pulsed field ablation, although the OMNYPULSE results remain investigational and VARIPULSE Pro is not yet approved in the U.S.
Johnson & Johnson (NYSE: JNJ) reported new clinical data for two pulsed field ablation platforms at the APHRS 2026 meeting, highlighting strong acute procedural results for VARIPULSE Pro and encouraging 12-month outcomes for the investigational OMNYPULSE system.
In the VARIPURE study, which included 225 patients across 19 European centers, the VARIPULSE Pro Platform achieved 100% acute procedural success. The study reported one primary adverse event, representing a 0.4% rate, with no reported stroke, coronary spasm, acute kidney injury or death. Mean ablation time was 17.9 minutes, and a single-catheter mapping-and-ablation workflow was used in 88.9% of cases.
VARIPULSE Pro is currently available in Europe, Japan and certain other international markets, but is not approved in the United States.
Separately, the Omny-IRE study evaluated 136 patients with symptomatic paroxysmal atrial fibrillation. At 12 months, 82.5% of patients remained free from documented atrial fibrillation, atrial flutter or atrial tachycardia recurrence under stringent monitoring, rising to 90.1% under standard-of-care monitoring. The reported adverse-event rate was 2.9%, and all safety events were resolved.
Patients treated with OMNYPULSE also showed a 25.5-point mean improvement in the Atrial Fibrillation Effect on Quality-of-Life score, along with reductions in antiarrhythmic medication use and cardiovascular-related hospitalizations. OMNYPULSE remains investigational and is not approved or available for sale.
Johnson & Johnson also cited real-world database results suggesting lower long-term atrial-fibrillation-related acute-care utilization with its CARTO 3 mapping system compared with EnSite, with patients treated using EnSite showing a 31% higher risk of AF/AFL/AT-related inpatient readmission or emergency-room visits in that analysis.
The findings add clinical evidence across Johnson & Johnson’s electrophysiology portfolio and support the company’s broader push into pulsed field ablation, although the OMNYPULSE results remain investigational and VARIPULSE Pro is not yet approved in the U.S.
