Biosense Webster, a part of Johnson & Johnson MedTech, has completed enrolment for the Omny-IRE clinical trial to assess Omnypulse Platform in atrial fibrillation (AFib) treatment.
The platform is designed for the mapping and treatment of symptomatic paroxysmal AFib during standard ablation procedures.
Conducted across multiple centres in Europe and Canada, the pivotal, multi-centre, prospective, non-randomised Omny-IRE study aims to demonstrate the Omnypulse Platform's safety and effectiveness.
Its primary focus is on the treatment of symptomatic paroxysmal AFib during standard electrophysiology mapping and ablation procedures, while also monitoring the incidence of primary adverse events within seven days post-procedure.
Comprising the Omnypulse Catheter and Trupulse Generator, the platform integrates pulsed field ablation (PFA) therapy with the CARTO 3 System's mapping capabilities.
The Omnypulse Catheter, currently under investigation, is the first large-tip, 12mm focal catheter with contact force sensing and a TRUEref reference electrode aimed at minimising the influence of far-field unipolar signals.
The Trupulse Generator, also investigational, delivers bipolar, biphasic pulses to the catheter's 12 electrodes.
Throughout the Omny-IRE trial, clinicians utilised the CARTO 3 System software to obtain a pulsed field index value for each ablation.
The Omnypulse Platform employs pulsed electrical field energy to create precise intracardiac lesions for AFib treatment.
Johnson & Johnson MedTech Cardiovascular & Specialty Solutions, Scientific Affairs vice-president Jennifer Currin said: “With the Omny-IRE trial now fully enrolled, we are continuing to make important progress in advancing our collective knowledge and understanding of PFA.
“Our hope is that the integrated OMNYPULSE Platform will be an exciting new tool in a versatile portfolio of PFA solutions that Biosense Webster is advancing to provide electrophysiologists with a suite of tools they need to deliver optimal procedures for their patients.”
In May 2024, Biosense launched CARTO 3 System Version 8, a 3D heart mapping system used in cardiac ablation procedures.
