SHERIDAN, WYOMING – May 5, 2025 – Johnson & Johnson MedTech has announced encouraging 3-month results from its pivotal Omny-IRE clinical trial, spotlighting the high-performance capabilities of its investigational OMNYPULSE™ Platform. Unveiled during the 2025 Heart Rhythm Society (HRS) Annual Meeting and simultaneously published in JACC Clinical Electrophysiology, the findings mark a strategic milestone in the company’s pulsed field ablation (PFA) portfolio expansion, with significant implications for patient care, procedural efficiency, and technology adoption in electrophysiology.
Breakthrough Results from the Omny-IRE Trial
The OMNYPULSE™ Platform demonstrated 100% acute pulmonary vein isolation (PVI) success and 84.5% PVI durability at three months, accompanied by a low 3.0% adverse event rate—only 0.7% of which were potentially catheter-related. These early outcomes suggest a strong balance of safety and efficacy in treating paroxysmal atrial fibrillation (PAF).
Conducted as a prospective, multi-center, non-randomized trial, Omny-IRE evaluates the OMNYPULSE™ Platform's integrated system, comprising:
- OMNYPULSE™ Catheter: The first 12 mm focal PFA catheter with contact force sensing and a TRUEref™ reference electrode for accurate signal detection.
- TRUPULSE™ Generator: A bipolar, biphasic pulse generator that drives ablation across 12 electrodes.
- CARTO™ 3 System: A real-time mapping system that supports precision targeting and procedural feedback via the Pulsed Field Index.
“The 3-month data provide encouraging early evidence of the OMNYPULSE™ Platform,” said Dr. Mattias Duytschaever of AZ Sint-Jan Hospital in Belgium. “What’s most compelling is the combination of 100% acute and strong remap success with a low rate of safety events.”
VARIPURE Registry Highlights Platform Accessibility and Safety
Complementing Omny-IRE’s findings, Johnson & Johnson MedTech also presented interim results from the ongoing VARIPURE registry. Encompassing 247 patients and 40 operators across 13 European sites, the study affirms the VARIPULSE™ Platform’s real-world reliability and scalability—critical factors as health systems seek efficient solutions to meet growing demand for atrial fibrillation treatment.
Key takeaways include:
- Zero serious adverse events or neurovascular complications.
- No complications related to coronary spasms.
- No measurable learning curve for first-time operators—highlighting ease of adoption.
“The VARIPULSE™ Platform has both a strong safety profile and is highly accessible to new users, enabling safe and consistent outcomes from the very first case,” noted Dr. Francis Bessière of Hôpital Cardiologique Louis Pradel, France.
Dual Energy Catheter Data Reinforce Predictive Precision
Further strengthening the company’s ablation strategy, preclinical data presented by Dr. Hiroshi Nakagawa validated the Pulse Field Index using the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter. Conducted on swine models, the study showed:
- Lesion depth predictions within ±1 mm accuracy in 92% of cases.
- Complete prediction accuracy within ±1.5 mm.
- Strong correlation between contact force, pulse count, and lesion depth.
These findings establish a scientifically grounded dosing protocol that enhances intraoperative confidence and real-time decision-making for electrophysiologists.
Strategic Alignment with Broader Industry Needs
Johnson & Johnson MedTech’s expanding PFA portfolio—spanning focal, regional, and dual energy solutions—reflects growing demand for advanced, integrated cardiac ablation systems that can:
- Improve procedural consistency and patient outcomes.
- Reduce complexity for new users through intuitive system design.
- Scale efficiently across varied clinical settings and expertise levels.
“Our PFA portfolio is built around what matters most to physicians—durability, control, safety and efficiency,” said Jennifer Currin, Ph.D., Vice President, Scientific Affairs at Johnson & Johnson MedTech. “The Omny-IRE, VARIPURE, and Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter data demonstrate our commitment to delivering safe, effective, and reliable PFA tools.”
With strong performance data and user-centric innovation, Johnson & Johnson MedTech is positioned to play a leading role in the rapidly evolving landscape of cardiac ablation.