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