Biosense Webster Achieves First-of-Its-Kind Approval for VARIPULSE™ PFA Platform in Japan

Biosense Webster, a prominent player in cardiac arrhythmia treatment and a part of the Johnson & Johnson MedTech family, has recently secured approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its VARIPULSE™ Platform. This approval specifically covers the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib) using pulsed field ablation (PFA). The VARIPULSE™ Platform is a comprehensive system comprising the VARIPULSE™ Catheter, a variable-loop multielectrode catheter; the TRUPULSE™ Generator, a multichannel PFA generator; and the CARTO™ 3 System, recognized as the world's leading 3D cardiac mapping system.

Notably, the VARIPULSE™ Platform stands out as the first and only CARTO™-integrated PFA system, offering an intuitive and reproducible workflow with real-time visualization and feedback mechanisms. The platform's distinctive pulse sequence, catheter design, and seamless integration with the CARTO™ 3 System contribute to a streamlined workflow, resulting in minimal fluoroscopy time (7.8 minutes) and efficient procedures (70 minutes).

Pulsed Field Ablation (PFA), a novel approach to treating AFib, employs a controlled electric field for selective ablation of cardiac tissue through irreversible electroporation (IRE). Unlike conventional methods such as radiofrequency ablation or cryoablation, PFA is characterized by minimal thermal impact, potentially lowering the risk of damage to surrounding tissues.

Atrial fibrillation (AFib) is acknowledged as the most prevalent cardiac arrhythmia globally, impacting nearly 38 million individuals worldwide, with around 1.3 million affected in Japan. Despite its widespread occurrence, there is a notable lack of awareness regarding AFib symptoms, available treatment options, and the critical importance of early intervention to mitigate the risk of stroke and disease progression.


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