Biosense Webster Requests U.S. FDA Approval for VARIPULSE™ Platform to Address Paroxysmal Atrial Fibrillation

Monday, March 25, 2024

Biosense Webster, a renowned provider of cardiac arrhythmia treatment solutions and a division of Johnson & Johnson MedTech, has officially submitted the VARIPULSE™ Platform for Premarket Approval Application (PMA) to the U.S. Food & Drug Administration (FDA). This submission is backed by findings from the admIRE study, a prospective, multi-center, non-randomized trial.

The VARIPULSE™ Platform consists of several components, including the VARIPULSE™ Catheter, which is a fully integrated variable-loop multielectrode catheter, the TRUPULSE™ Generator, a pulsed field ablation (PFA) generator, and the CARTO™ 3 System VARIPULSE™ Software, offering seamless integration with the leading 3D cardiac mapping system worldwide.

Designed to facilitate pulmonary vein isolation with the versatility of a catheter loop, the VARIPULSE™ Platform features a user-friendly generator interface and a mapping system that ensures an intuitive, reproducible workflow with real-time visualization, contact indicator, and PF tagging mechanisms. President of Biosense Webster, Inc., Jasmina Brooks, expressed confidence in the innovation's potential to deliver significant value and distinctive capabilities, ultimately serving as a crucial tool in atrial fibrillation (AFib) treatment.

AFib, the most common type of cardiac arrhythmia, affects millions of individuals globally, with a significant population in the United States alone. Despite its prevalence, awareness of AFib symptoms, available treatments, and the importance of early intervention remains limited. Catheter ablation emerges as a safe and effective procedure for restoring normal heart rhythm when medications prove ineffective.

This submission marks a milestone in advancing treatment options for AFib patients, reflecting Biosense Webster's commitment to developing comprehensive solutions to meet the diverse needs of electrophysiologists and their patients.

Source: prnewswire.ocm



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