Johnson & Johnson MedTech has received the US Food and Drug Administration (FDA) approval for its VARIPULSE Platform to treat drug-refractory paroxysmal atrial fibrillation (AFib).
This system is designed to deliver treatment using a single device that integrates Pulsed Field Ablation (PFA) therapy with advanced mapping capabilities.
The VARIPULSE Platform, which works in conjunction with the CARTO 3 Electro-anatomical Mapping System, enhances the safety and accuracy of ablation procedures by providing precise energy delivery and real-time catheter positioning visualisation.
It also enables minimal- to zero-fluoro workflow through its integration with an intracardiac echocardiography (ICE) ultrasound portfolio, offering imaging in real time.
Electrophysiologists can gain confidence in the treatment delivered through tissue proximity indication and lesion tagging.
The platform also allows for a single transseptal zero exchange workflow, making procedures efficient and predictable.
It provides a comprehensive solution for routine as well as complex AFib ablations.
Johnson & Johnson MedTech Electrophysiology president Jasmina Brooks said: “With this approval, we are excited to bring the VARIPULSE Platform to electrophysiologists and patients in the US, where AFib impacts nearly eight million people.
“As the only PFA platform uniquely designed for seamless integration with the CARTO 3 System, we are confident that this eagerly awaited platform will be a valuable tool for physicians in performing safe, effective and efficient AFib procedures with an intuitive and reproducible workflow, and minimal-to-no fluoroscopy.”
The FDA's approval is backed by data from the admIRE prospective, multi-centre, non-randomised study.
Among 291 patients treated across 30 US healthcare centres, acute procedural success was achieved in 100% of cases, including 98% with first-pass isolation per vein.
Additionally, 85% reached peak primary effectiveness with minimal adverse events reported at only 2.9% while 25% of procedures were conducted without fluoroscopy.
Earlier this month, Johnson & Johnson MedTech concluded subject enrolment for the pilot phase of the OMNY-AF study of the investigational OMNYPULSE Platform for treating symptomatic paroxysmal AFib in Australia and the US.
