Johnson & Johnson Reports First Real-World VARIPULSE Pro Platform Data and 12-Month OMNYPULSE Platform Outcomes for Atrial Fibrillation Treatment at APHRS 2026
Key Highlights
- ➤VARIPULSE Pro delivered 100% acute procedural success across 225 patients.
- ➤VARIPULSE Pro recorded a 0.4% primary adverse event rate and 17.9-minute mean ablation time.
- ➤OMNYPULSE showed 82.5% freedom from documented atrial arrhythmia recurrence at 12 months.
- ➤CARTO 3 users had lower long-term AF-related acute-care utilization than EnSite users.
- ➤EnSite-treated patients faced 31% higher risk of AF-related readmissions or emergency visits.
Expert Statements
Gregory Michaud, Chief Medical and Scientific Officer, Electrophysiology, Johnson & Johnson
“The data presented at APHRS demonstrate the progress we are making across our pulsed field ablation (PFA) pipeline and portfolio”
Gregory Michaud, Chief Medical and Scientific Officer, Electrophysiology, Johnson & Johnson
“The acute safety and efficiency results from VARIPULSE Pro and 12-month outcomes with the investigational OMNYPULSE Platform strengthen the clinical evidence supporting our differentiated technologies as we work to advance atrial fibrillation care for physicians and patients.”
Leon Iden, Head of the Electrophysiology Department, Herzzentrum Bad Segeberg, Germany
“The VARIPURE study provides the first real-world data for VARIPULSE Pro”
Leon Iden, Head of the Electrophysiology Department, Herzzentrum Bad Segeberg, Germany
“The findings on safety, acute procedural success and catheter versatility, together with conveniently short ablation duration, highlight the potential to streamline PFA procedures and help physicians deliver efficient, consistent care across a broad range of patients with atrial fibrillation.(i)”
Tom De Potter, Head of Electrophysiology and Associate Director of the Heart Center, OLV Hospital, Aalst, Belgium
“For physicians evaluating new PFA technologies, sustained effectiveness at 12 months is a key measure of whether strong acute results translate into meaningful outcomes over time,”
Tom De Potter, Head of Electrophysiology and Associate Director of the Heart Center, OLV Hospital, Aalst, Belgium
“The Omny-IRE findings are encouraging because they extend beyond meeting the effectiveness and safety endpoints or collecting quality of life and healthcare utilization data(ii), helping us better understand what treatment with the investigational OMNYPULSE Platform could mean for both physicians and patients.”
Johnson & Johnson Reports First Real-World VARIPULSE Pro Platform Data and 12-Month OMNYPULSE Platform Outcomes for Atrial Fibrillation Treatment at APHRS 2026
VARIPURE findings reported 100% acute procedural success with the VARIPULSE Pro Platform, 0.4% primary adverse event rate and a mean ablation time of 17.9 minutes(i)
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