MHLW approval of Varipulse pulsed field ablation (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 Varipluse Platform is the first and only Carto-integrated PFA system, enabling an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.
“At Biosense Webster, we are working to deliver a differentiated PFA portfolio integrated with 3D cardiac mapping to address the real-world, unmet needs of electrophysiologists and the patients they treat. Today, we celebrate this milestone approval of the Varipulse Platform, the first and only PFA system approved in Japan,” said Jasmina Brooks, President, Biosense Webster. “We are excited to continue to advance PFA clinical studies globally and look forward to the positive impact this innovation will deliver to patients everywhere.”
The inspIRE trial early clinical results with the Varipluse 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%)1. 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.)
“The innovation in catheter ablation therapy for atrial fibrillation has been remarkable. The approval of ablation therapy using pulsed-field energy in Japan will further advance the treatment of arrhythmias. Together with the integrated 3D mapping system, this innovation has the potential to provide more advanced treatment and further improve safety”, said Dr. Wataru Shimizu, President of the Japan Heart Rhythm Society (Professor, Department of Cardiovascular Medicine, Graduate School of Medicine, Nippon Medical School)ii . “The increasing diversity of treatment technologies means that healthcare providers who seek to cure atrial fibrillation have options tailored to each patient’s condition.”
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.
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 risk of stroke and disease progression.
The Varipluse Platform is pending CE mark in the Europe. It is not available for sale in the EU or United States..
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