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

November 7, 2024
1:38 pm

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, the world’s leading 3D electroanatomical cardiac mapping system. Strategically developed for full integration with CARTO™, the VARIPULSE™ Platform enables:

The accuracy and safety of ablation procedures through precise energy delivery and real-time visualization of catheter positioning^2,ii
Minimal- to zero-fluoro workflow through seamless integration with the intracardiac echocardiography (ICE) ultrasound portfolio providing real-time imaging³^,4,5
Confidence in treatment delivered through tissue proximity indication and lesion tagging, providing electrophysiologists with feedback that has proven to be critical for lesion durability and long-term outcomes
A single transseptal zero exchange workflow for an efficient and predictable procedure
A comprehensive solution to seamlessly address both routine and complex AFib ablations^2,iii

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

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