Varipulse treats AFib with a single device that combines PFA with the Carto 3 mapping system. With approval, Johnson & Johnson joins Medtronic and Boston Scientific as companies with PFA technologies approved for treating AFib.
Medtronic’s PulseSelect PFA system this year became the first to win FDA approval for AFib. Boston Scientific became the second company to win FDA approval for PFA with its Farapulse system in January. Medtronic added to its offerings last month with an FDA nod for its Affera mapping and ablation system with the Sphere-9 catheter.
Varipulse features the variable-loop, multielectrode Varipulse catheter. The platform also includes TruPulse generator and the Carto 3 3D cardiac mapping system. According to J&J’s Biosense Webster, Carto integration enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.
Johnson & Johnson says it delivers accuracy and safety in ablation procedures through precise energy delivery and real-time visualization of catheter positioning. It has minimal- to zero-fluoroscopy workflows through integration with intracardiac echocardiography (ICE) ultrasound.
Approval comes on the back of results from the adMIRE study, which demonstrated Varipulse’s safety and efficacy.
“With this approval, we are excited to bring the Varipulse Platform to electrophysiologists and patients in the U.S., where AFib impacts nearly eight million people,” said Johnson & Johnson MedTech Electrophysiology President Jasmina Brooks. “As the only PFA platform uniquely designed for seamless integration with the Carto 3 System, we are confident that this eagerly awaited platform will be a valuable tool for physicians in performing safe, effective and efficient AFib procedures with an intuitive and reproducible workflow, and minimal-to-no fluoroscopy.”
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