Sam Brusco, Associate Editor03.25.24
Bionsense Webster, a Johnson & Johnson MedTech company, has submitted its Varipulse pulsed field ablation (PFA) platform for premarket approval (PMA) to the U.S. Food and Drug Administration (FDA).
The submission was supported by data from the company’s admIRE study. Among 20 patients who completed the trial’s 12-month follow-up visit, all achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence at one year.
No procedure or device-related primary adverse events were reported in the pilot phase of the study, according to the company. For patients who had received ablation, median procedure and fluoroscopy times were 90.0 and 3.5 minutes, respectively, likely attributable to integration with the Carto 3 system.
The Varipulse platform consists of a variable-loop multielectrode catheter, PFA generator, and Carto 3 system Varipulse software. It’s designed to enable pulmonary vein isolation with the versatility of a catheter loop, a simple generator user interface, and a mapping system that provides an intuitive, reproducible workflow with real-time visualization, contact indicator, and PF tagging mechanisms.
"The VARIPULSE Platform, differentiated by its CARTO 3 System integration and mapping capabilities, is part of a versatile portfolio of PFA tools that Biosense Webster is developing to meet the varied needs of electrophysiologists and their patients," said Jasmina Brooks, president of Biosense Webster. "Based on the results from the admIRE clinical trial, we are confident that this innovation has the promise to deliver significant value and differentiated capabilities, and become an important tool for the treatment of AFib."
Last month, the company gained CE mark approval for the Varipulse PFA system.
The submission was supported by data from the company’s admIRE study. Among 20 patients who completed the trial’s 12-month follow-up visit, all achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence at one year.
No procedure or device-related primary adverse events were reported in the pilot phase of the study, according to the company. For patients who had received ablation, median procedure and fluoroscopy times were 90.0 and 3.5 minutes, respectively, likely attributable to integration with the Carto 3 system.
The Varipulse platform consists of a variable-loop multielectrode catheter, PFA generator, and Carto 3 system Varipulse software. It’s designed to enable pulmonary vein isolation with the versatility of a catheter loop, a simple generator user interface, and a mapping system that provides an intuitive, reproducible workflow with real-time visualization, contact indicator, and PF tagging mechanisms.
"The VARIPULSE Platform, differentiated by its CARTO 3 System integration and mapping capabilities, is part of a versatile portfolio of PFA tools that Biosense Webster is developing to meet the varied needs of electrophysiologists and their patients," said Jasmina Brooks, president of Biosense Webster. "Based on the results from the admIRE clinical trial, we are confident that this innovation has the promise to deliver significant value and differentiated capabilities, and become an important tool for the treatment of AFib."
Last month, the company gained CE mark approval for the Varipulse PFA system.