JnJ Medtech's Biosense Webster gets nod for VARIPULSE Pulsed Field Ablation platform in Japan
Irvine: Johnson & Johnson MedTech's Biosense Webster, Inc. has 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, a 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.
“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. 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.”
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