Johnson & Johnson MedTech Secures FDA Approval for Varipulse PFA System to Treat AFib

Johnson & Johnson MedTech’s Varipulse pulsed field ablation (PFA) platform has received FDA approval for treating atrial fibrillation (AFib), adding another cutting-edge tool to the AFib treatment landscape. The Varipulse system uniquely combines PFA technology with the Carto 3D mapping system, which enhances the accuracy of energy delivery and provides real-time visualization during procedures, all while allowing for minimal-to-zero fluoroscopy through ICE ultrasound integration. This FDA approval positions J&J alongside Medtronic and Boston Scientific, two other leaders in PFA technologies approved for AFib treatment.

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The Varipulse platform’s advanced features, including the variable-loop catheter and TruPulse generator, support a safe, precise ablation process. Approved following positive results from the adMIRE study, Varipulse aims to improve workflow efficiency for electrophysiologists while enhancing patient outcomes. “With nearly eight million people affected by AFib in the U.S., we’re thrilled to offer this intuitive platform to support physicians in performing effective and safer AFib procedures,” said Jasmina Brooks, President of Electrophysiology at Johnson & Johnson MedTech.