The temporary pause follows reports of four cases of neurovascular events in the US external evaluation study.
“Out of an abundance of caution,” Johnson & Johnson MedTech has temporarily paused the use of its Varipulse field ablation system in the United States, the
Johnson & Johnson did not provide details on the four cases, but said it expects to provide more information “within the coming days.” The company said it is “working diligently to complete the investigation according to our medical safety processes and resume the US external evaluation.”The fully integrated platform is designed to enable the treatment of atrial fibrillation with a single device that combines pulsed field ablation therapy and advanced 3D navigation and cardiac mapping.
AF Afib A-Fib Afib Afib Atrial Fib Atrial Fibrillation (AF) Atrial Fibrillation (A-Fib) Ablation U.S. Food And Drug Administration United States Food And Drug Administration FDA Food And Drug Administration (FDA) Food And Drug Administration Paroxysmal Atrial Fibrillation Isolation Quarantine Veins Canada Canadian Europe European Fluoroscopy
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