Source:Medtech Dive,Reproduction without authorization is prohibited, and reproduction is allowed 24 hours later.

Johnson & Johnson MedTech announced yesterday,Its Varipulse Pulse Field Ablation (PFA) platform has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of atrial fibrillation (AFib).

Varipulse Platform Achieves Innovative Breakthrough in Atrial Fibrillation Treatment by Integrating PFA Technology with the Carto 3 Mapping System. This approval makes Johnson & Johnson Medical Technologies the third company, after Medtronic and Boston Scientific, to have an approved PFA technology for treating atrial fibrillation. In the PFA sector, a showdown among giants is imminent.

Looking back at this year,Medtronic was the first to receive FDA approval for its PulseSelect PFA System for the treatment of atrial fibrillation, followed by Boston Scientific, which gained approval in January with its Farapulse system.Medtronic further expanded its product line last month, with its Sphere-9 catheter Affera mapping and ablation system also receiving FDA approval.

The highlight of the Varipulse platform lies in its unique variable loop, multi-electrode design, as well as the配套的TruPulse generator and Carto 3 three-dimensional cardiac mapping system. According to Biosense Webster, a subsidiary of Johnson & Johnson, the integration of Carto enables the platform to provide an intuitive and repeatable workflow, with real-time visualization and feedback functions.

Johnson & Johnson Medical Technologies emphasized that the Varipulse platform ensures a high level of accuracy and safety in ablation procedures through precise control of energy delivery and real-time visualization of catheter positioning. Additionally, the platform's integration with intracardiac echocardiography (ICE) minimizes or even eliminates the use of fluoroscopy, further enhancing the convenience and safety of the procedure.

This approval is based on the results of the adMIRE study, which fully validated the safety and efficacy of the Varipulse platform. Among 291 patients across 30 healthcare centers in the United States, 100% of the cases were acute procedures, with first ablation recorded in 98% of the patients' veins. When 73-96 applications were delivered per vein (n=85), 85% of patients achieved peak primary effectiveness, with minimal adverse events (2.9%), and 25% of the procedures were performed without fluoroscopy, potentially attributed to the integrated advantages of the Carto 3 system.

Jasmina Brooks, President of Johnson & Johnson Medical Technologies' Electrophysiology Division, stated: "We are very pleased to bring the Varipulse platform to electrophysiologists and patients in the United States, as atrial fibrillation affects the health of nearly 8 million people in the U.S. As the only PFA platform specifically designed for seamless integration with the Carto 3 system, we believe that Varipulse will become an invaluable tool for physicians performing atrial fibrillation procedures. Its intuitive and repeatable workflow, along with minimal fluoroscopy requirements, will greatly enhance the safety and efficiency of these procedures."

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