Johnson & Johnson MedTech Receives FDA Approval for the VARIPULSE™ Pulsed Field Ablation Platform for the Treatment of Atrial Fibrillation

The VARIPULSE™ Platform is the first and only Pulsed Field Ablation (PFA) System in the U.S. fully integrated with the CARTO™ 3 Electro-anatomical Mapping System, driving efficiency, reproducibility and accuracy1

Approval is supported by the admIRE study, where 85% peak primary effectiveness 12-month success and minimal-to-no fluoroscopy were achieved2,i

IRVINE, Calif., Nov. 7, 2024 /PRNewswire/ -- Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the U.S. Food & Drug Administration (FDA) approval of the VARIPULSE™ Platform for the treatment of drug refractory paroxysmal Atrial Fibrillation (AFib).

The VARIPULSE™ Platform is designed to enable AFib treatment with a single device that combines PFA therapy and advanced mapping with the CARTO™ 3 System.

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The VARIPULSE™ Platform is fully integrated with the CARTO™ 3 mapping system, which provides lesion indexing and electrode-tissue proximity indication for electrophysiologists performing catheter ablation procedures.

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Variable catheter loop size (25mm-35mm) to adjust to the patient’s anatomy.

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The VARIPULSE™ Platform is now approved by the U.S. Food & Drug Administration for electrophysiologists to use in catheter ablation procedures for the treatment of paroxysmal atrial fibrillation.

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The VARIPULSE™ Platform is now approved by the U.S. Food & Drug Administration for electrophysiologists to use in catheter ablation procedures for the treatment of paroxysmal atrial fibrillation.

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Variable catheter loop size (25mm-35mm) to adjust to the patient’s anatomy.

if video/audio/not yotube

Variable catheter loop size (25mm-35mm) to adjust to the patient’s anatomy.

if video/audio/not yotube