J&J MedTech 3-Month Data Supports Omnypulse PFA

Johnson & Johnson MedTech shared positive, initial three-month results from its Omny-IRE study, which is evaluating the investigational Omnypulse platform in patients with paroxysmal atrial fibrillation (PAF).

The data, revealed at this year’s Heart Rhythm Society annual meeting, showed 100% acute pulmonary vein isolation (PVI) with durable isolation in 84.5% of pulmonary veins at three-month remapping. There was a 3% primary adverse event rate, with 0.7% being possible catheter related.

The clinical trial is assessing Omnypulse to map and treat symptomatic PAF during standard ablation procedures. Omnypulse consists of the Omnypulse pulsed field ablation (PFA) catheter and the Trupulse generator, and is integrated with the Carto 3 mapping system.

The Omnypulse catheter, according to J&J, is the first large-tip, 12 mm focal catheter with contact force sensing and a reference electrode to reduce impact of far-field unipolar signals. The Trupulse generator offers a bipolar, biphasic pulse application to the catheter’s twelve electrodes.

Using Carto 3, clinicians could obtain a Pulsed Field (PF) Index value for each ablation, a calculation using the real-time force feedback combined with the number of pulsed field applications.

“The 3-month data provide encouraging early evidence of the OMNYPULSE Platform,” said Mattias Duytschaever MD, Ph.D., Department of Cardiology, Electrophysiology Section, AZ Sint-Jan Hospital, Brugge, Belgium. “What’s most compelling is the combination of 100% acute and strong remap success 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.”

Data from the VARIPURE study, which is evaluating the real-world safety and learning curve of the Varipulse platform PVI procedures for atrial fibrillation. The study included 247 patients and 40 operators with varying levels of experience, including first-time users.

No serious adverse events were reported and no complications linked to the platform. Among a subset of 115 patients treated by operators performing their first ten Varipulse cases, results showed no measurable learning curve beyond a modest reduction in idle time between ablations.

A new preclinical validation of a PF Index from the Dual Energy Thermocool Smarttouch SF catheter was also shared. It leveraged data from lesions created in a swine beating heart model. The analysis confirmed that lesion depth, which is crucial for effective treatment, correlates strongly with the number of PFA pulses and contact force using a logarithmic PF Index—accurately predicting lesion depth within ±1 mm in 92% of cases and ±1.5 mm in all cases.

“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, 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.”