Biosense Webster has submitted a premarket approval application (PMA) to the US Food & Drug Administration (FDA) for its Varipulse platform. The submission was supported by results from the admIRE study, a prospective, multicentre, non-randomised trial.
The Varipulse platform is comprised of the Varipulse catheter, a fully integrated variable-loop multielectrode catheter; the Trupulse generator, a pulsed field ablation (PFA) generator; and the Carto 3 system Varipulse software, which provides full integration with the 3D cardiac mapping system.
The Varipulse platform is designed to enable pulmonary vein isolation (PVI) 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 visualisation, 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, 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 atrial fibrillation (AF).”
Twelve-month outcomes data from the pilot phase of the admIRE study, which assessed the safety and efficacy of the Varipulse platform among US patients, were presented as a late-breaker at the 2024 AF Symposium (1–3 February, Boston, USA).
Among 20 patients who completed the 12-month follow-up visit, 100% 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. For patients who had received ablation, median procedure and fluoroscopy times were 90 and 3.5 minutes, respectively. Full admIRE study results will be presented later this year.
