Johnson & Johnson MedTech division Biosense Webster has submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for its VARIPULSE Platform, designed to treat paroxysmal atrial fibrillation.
The application is supported by findings from the admIRE study, which evaluated the safety and efficacy of the platform in US patients.
The VARIPULSE Platform includes the VARIPULSE Catheter, a fully integrated variable-loop multielectrode catheter; a pulsed field ablation (PFA) generator, TRUPULSE Generator; and the CARTO 3 System VARIPULSE Software.
This combination aims to provide a versatile and intuitive workflow for pulmonary vein isolation procedures.
Data from the pilot phase of the admIRE study showed promising results.
Following a 12-month follow-up, 100% of the 20 patients achieved acute success, and 80% were free from atrial arrhythmia recurrence after one year. Primary adverse events were not reported related to the procedure or device.
The admIRE study's pilot phase focused on initial device safety and effectiveness, while the pivotal phase compared these outcomes against pre-defined performance goals.
The primary safety endpoint included the incidence of early-onset primary adverse events and other complications within specified timeframes. The study also assessed acute procedure success and freedom from atrial arrhythmia recurrence at 12 months.
Biosense Webster president Jasmina Brooks said: “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.
“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.”
While the VARIPULSE Platform is currently investigational in the US, the TRUPULSE Generator received a CE mark in Europe in late 2023.
Prior to this development, Biosense Webster secured European CE mark approval for its Varipulse pulsed field ablation (PFA) platform.
