Omnypulse features the Omnypulse catheter and the Trupulse generator. The company offers the catheter as a large-tip, 12 mm device with Carto 3 system integration. It features contact force feedback and enhanced mapping capabilities. Altogether, it combines pulsed field ablation (PFA) therapy and mapping.
The investigational Trupulse generator delivers a bipolar, biphasic pulse sequence to the catheter’s 12 electrodes during cardiac ablation. It features contact force sensing and the Trueref reference electrode, reducing the impact of far-field unipolar signals. J&J said it designed the platform to enable AFib strategies with a single device. It combines a large ablation area with the ability to create high-density maps.
Investigators presented their Omnypulse findings at the 2025 Heart Rhythm Society (HRS) annual meeting. They simultaneously published them in JACC Clin Electrophysiology.
“The 3-month data provide encouraging early evidence of the Omnypulse platform,” said Dr. Mattias Duytschaever, Department of Cardiology, Electrophysiology Section, AZ Sint-Jan Hospital, Brugge, Belgium. “What’s most compelling is the combination of 100% acute and strong remap success1 with a low rate of safety events. These results reinforce the potential of Omnypulse and its integration with the CARTO 3 system to deliver reproducible, durable outcomes for patients with paroxysmal AFib.”
A look at the findings from the Johnson & Johnson MedTech Omnypulse study
Omny-IRE evaluates Omnypulse in the treatment of patients with paroxysmal AFib (PAF). A 12-month clinical trial, it evaluates the safety and efficacy of Omnypulse in mapping and treating symptomatic PAF during standard ablation procedures.
Johnson & Johnson MedTech reported that Omnypulse demonstrated the potential for both high acute effectiveness with a promising safety profile.
Findings included 100% acute pulmonary vein isolation (PVI). Omnypulse had durable isolation in 84.5% of pulmonary veins at three-month remapping and a 3% primary adverse event rate. Only 0.7% of those proved potentially catheter-related.
More PFA data from J&J
In addition to the Omnypulse data, J&J also shared VARIPURE findings for its Varipulse platform in PVI for AFib. Across 13 European sites, the post-market study included 247 patients and 40 operators with varying experience. Some were first-time users.
Notably, the study saw zero serious adverse events and no complications, including zero neurovascular events or coronary spasms. The company resumed sales for Varipulse in February after a temporary pause due to reports of neurovascular events.
In a subset of 115 patients treated by operators performing their first 10 Varipulse cases, results showed no measurable learning curve beyond a modest reduction in idle time between ablations. J&J says this underscores the efficiency and ease of adopting the technology.
Dr. Hiroshi Nakagawa, meanwhile, shared new preclinical validation of a PF index from the J&J dual-energy ThermoCool SmartTouch SF catheter. It leveraged data from lesions created in a swine beating heart module. The analysis confirmed that lesion depth, which is crucial for effective treatment, correlates strongly with the number of PFA pulses and contact force.
Johnson & Johnson MedTech says its findings advance the clinical and technical validation of its PFA portfolio. This spans across focal, regional and dual-energy catheter designs.
“Our PFA portfolio is built around what matters most to physicians—durability, control, safety and efficiency,” said Jennifer Currin, VP, Scientific Affairs, 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.”
