BIOSENSE WEBSTER ANNOUNCES REGULATORY APPROVAL OF VARIPULSE PFA PLATFORM IN JAPAN

Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the VARIPULSE™ Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib) using pulsed field ablation (PFA). The VARIPULSE™ Platform is comprised of the VARIPULSE™ Catheter, a variable-loop multielectrode catheter; the TRUPULSE™ Generator, a multichannel PFA generator; and CARTO™ 3 System, the world’s leading 3D cardiac mapping system. The VARIPULSE™ Platform is the first and only CARTO™-integrated PFA system, enabling an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.

The inspIRE trial early clinical results with the VARIPULSE™ Platform in Europe demonstrated a one-year clinical success of 78.9%, defined as freedom from documented symptomatic atrial arrhythmia recurrence. The trial also demonstrated a notable safety profile, reporting no primary adverse events (0%). The platform’s proprietary pulse sequence, catheter design, and CARTO™ 3 System integration enabled a simplified workflow and resulted in minimal fluoroscopy time (7.8 minutes) and efficient procedures (70 minutes).

Catheter ablation is a minimally invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AFib, by interrupting irregular electrical pathways in the heart by delivering either heat (radiofrequency ablation) or cold (cryoablation). PFA represents a new approach to treating AFib, utilizing a controlled electric field to selectively ablate cardiac tissue that causes an irregular heartbeat through a process called irreversible electroporation (IRE). Because the pulsed field energy is minimally thermal, IRE offers the potential to reduce the risk of damage to surrounding tissues including esophageal, pulmonary vein, and phrenic nerve injury.

AFib is the most common type of cardiac arrhythmia, impacting nearly 38 million people worldwide and approximately 1.3 million people in Japan. Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options and the importance of early treatment to avoid the risk of stroke and disease progression.

The VARIPULSE™ Platform is pending CE mark in the European Union; it is not available for sale in the EU or United States.