Biosense Webster completes enrollment for pulsed field ablation study

Johnson & Johnson MedTech's Biosense Webster today announced that patient enrollment in the Omny-IRE pulsed field ablation (PFA) study has been completed.

The prospective, multicenter, nonrandomized study enrolled 188 patients in Europe and Canada and is evaluating the safety and efficacy of the company's Omnypulse platform, which the J&J division developed for mapping and treating symptomatic paroxysmal atrial fibrillation during standard ablation procedures.

Biosense Webster's Omnypulse platform includes the Omnypulse catheter and the Trupulse generator. The company offers the catheter as a 12 mm large tip device with Carto 3 system integration. It features contact force feedback and advanced mapping capabilities.

The experimental Tripulse generator delivers a bipolar, biphasic pulse train to the catheter's 12 electrodes during cardiac ablation. It features contact force sensing and the Trueref reference electrode, which reduces the effects of unipolar signals in the far field. Biosense Webster said it developed the platform to enable AFib strategies with a single device. It combines a large ablation area with the ability to create high-density maps.

The company says that using PFA in the irreversible electrocorporation (IRE) procedure can reduce the risk of damage to surrounding tissue, including injuries to the esophagus, pulmonary vein and phrenic nerve.

“With the Omny-IRE study now fully completed, we continue to make important progress in expanding our collective knowledge and understanding of PFA,” said Jennifer Currin, vice president of scientific affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech. “We hope the integrated Omnypulse platform will be an exciting new tool in a diverse portfolio of PFA solutions that Biosense Webster is advancing to provide electrophysiologists with a set of tools they need to provide optimal practices to their patients.”

Biosense Webster gains coverage in Japan

In addition to the Omnypulse news, Biosense Webster announced that Japanese authorities have approved coverage of its Varipulse system.

From September 1, 2024, the system – another PFA platform – will be covered by health insurance in Japan. It is the first atrial fibrillation treatment with PFA to be covered by health insurance in Japan.

The Varipulse system includes the Varipulse catheter, a multi-electrode variable loop catheter. The platform also includes the 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, a simple generator user interface, and an intuitive mapping system. It also features contact indicators and PF marking mechanisms.

The company submitted Varipulse to the FDA for approval at the end of March. If approved, Varipulse would be the third PFA system approved for the treatment of atrial fibrillation, after Medtronic and Boston Scientific.