Johnson & Johnson MedTech division Biosense Webster has secured European CE mark approval for its Varipulse pulsed field ablation (PFA) platform.
Integrated with the CARTO 3D Cardiac Mapping System, the system is designed for the treatment of symptomatic drug-refractory recurrent paroxysmal atrial fibrillation (AF).
The Platform consists of the VARIPULSE Catheter, the TRUPULSE Generator, and the CARTO 3 System.
It is the first and only CARTO-integrated PFA system, enabling real-time visualisation and feedback, which facilitates an intuitive and reproducible workflow.
Biosense Webster president Jasmina Brooks said: “At Biosense Webster, we continually seek to push the boundaries of science and technology innovation in cardiac ablation.
“CE mark approval of the Varipulse Platform is a testament to this, now offering healthcare professionals the potential to improve outcomes for people living with atrial fibrillation while setting a new standard in cardiac electrophysiological mapping.
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“We believe pulsed field ablation has the potential to offer safer, more consistent and efficient workflows, and the Varipulse Platform uniquely offers physicians a simple and reproducible PFA workflow with 3D visualisation, in real-time.”
Recently, Biosense received approval for the Varipulse platform in Japan.
Last month, Biosense Webster reported 12-month results from the inspIRE and admIRE trials, demonstrating month freedom from atrial arrhythmia recurrence in 80% of the patients with the use of the Varipulse platform.
The multicentre study of the treatment of PFA using Varipulse with irreversible electroporation (inspIRE trial – NCT04524364) enrolled patients with drug-refractory PAF.
From March 2021 to May 2022, the study was conducted across Canada and Europe. Of the 186 patients, 75.6% achieved the primary endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence.
Additionally, the study reported a fluoroscopy time of 7.8 minutes and a primary adverse event rate of 0.0%.
