Johnson & Johnson MedTech gets updated FDA nod for Varipulse PFA

Johnson & Johnson MedTech (NYSE: JNJ)+ today announced FDA approval for an update to its Varipulse platform’s irrigation flow rate.

The company stated that the update to its pulsed field ablation (PFA) platform reflects its commitment to advancing PFA innovation. Its update came on the back of real-world clinical practice.

Johnson & Johnson MedTech’s Varipulse platform treats AFib with a single device that combines PFA with the Carto 3 mapping system. Its variable-loop, multi-electrode Varipulse catheter uses laser-cut nitinol tubing for its loop shape. The platform also includes TruPulse generator and the Carto 3 3D cardiac mapping system.

The company joined Medtronic and Boston Scientific as companies with PFA technologies approved for treating AFib when it received an FDA nod in November 2024. Commercial activity hit a snag earlier this year when the company temporarily halted all U.S. cases using Varipulse in January. After reviewing four reported neurovascular events, the company resumed sales a month later.

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