Biosense Webster Unveil Successful Outcomes from Varipulse Atrial Arrhythmia Studies

Biosense Webster, a division of Johnson & Johnson MedTech, has disclosed the findings from the inspIRE and admIRE studies from the last year, showcasing an 80% incidence of freedom from atrial arrhythmia recurrence for patients utilizing the Varipulse platform.  

The Varipulse platform comprises a unified variable-loop multi-electrode catheter, a multi-channel pulsed field ablation generator, a Trupulse generator, and a 3D cardiac mapping system.  

At the start of the year, the Japan Ministry of Health, Labour and Welfare granted approval for the management of drug-resistant recurrent paroxysmal atrial fibrillation using the system. In Europe, although the Trupulse generator obtained a CE mark, the Varipulse catheter did not receive such certification.  

In the United States, neither the Trupulse generator nor the Varipulse catheter have been accepted by the FDA.  

The research took place between March 2021 and May 2022, spanning Canada and Europe. Out of just over 180 participants, 75% successfully reached the primary objective of pulmonary vein isolation, resulting in a yearlong freedom from recurrent atrial arrhythmia. 

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