Johnson & Johnson MedTech’s Biosense Webster announced today that it completed enrollment in its Omny-IRE pulsed field ablation (PFA) trial.
The prospective, multi-center, non-randomized trial enrolled 188 patients in Europe and Canada. It evaluates the safety and effectiveness of the company’s Omnypulse platform. The J&J unit designed it for mapping and treating symptomatic paroxysmal AFib during standard ablation procedures.
Biosense Webster’s Omnypulse platform 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.
The investigational Tripulse 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. Biosense Webster 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.
Using PFA through the irreversible electrocorporation (IRE) process, the company says it could reduce the risk of damage to surrounding tissues. That includes esophageal, pulmonary vein and phrenic nerve injury.
“With the Omny-IRE trial now fully enrolled, we are continuing to make important progress in advancing our collective knowledge and understanding of PFA,” said Jennifer Currin, VP, scientific affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech. “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.”
Biosense Webster earns coverage win in Japan
In addition to the Omnypulse news, Biosense Webster announced that Japanese authorities approved coverage of its Varipulse system.
From Sept. 1, 2024, the system — another PFA platform — will be covered by insurance in the country. It marks the first AFib treatment using PFA to earn insurance coverage in Japan.
The Varipulse system features the Varipulse catheter, a variable-loop multielectrode catheter. The platform also includes TruPulse generator and the Carto 3 3D cardiac mapping system. Carto integration enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms. The company designed Varipulse to enable pulmonary vein isolation with the versatility of a catheter loop, simple generator user interface and an intuitive mapping system. It also features contact indicators and PF tagging mechanisms.
The company submitted Varipulse for FDA approval at the end of March. If approved, Varipulse would become the third PFA system authorized for treating AFib, following Medtronic and Boston Scientific.
