Biosense Webster has today 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 (AF) 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, 3D cardiac mapping system.
“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 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 Wataru Shimizu (Nippon Medical School, Tokyo, Japan), president of the Japan Heart Rhythm Society. “The increasing diversity of treatment technologies means that healthcare providers who seek to cure atrial fibrillation have options tailored to each patient’s condition.”
PFA represents a new approach to treating AF, utilising 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 oesophageal, pulmonary vein, and phrenic nerve injury.
