Johnson & Johnson MedTech (J&J MedTech) has received the US Food & Drug Administration (FDA) approval for its Varipulse platform to treat drug-refractory paroxysmal Atrial Fibrillation (AFib).
The Varipulse Platform is a pulsed field ablation (PFA) system that comprises the Varipulse Catheter, Trupulse Generator, and CARTO 3 Mapping System.
CARTO 3 is a 3D electro-anatomical cardiac mapping system that enhances mapping capabilities to simplify procedures, reduce procedure time, and improve outcomes.
The FDA approval of the Varipulse platform is based on data from the admIRE study, a multi-centre, non-randomised clinical trial in 291 patients across 30 healthcare centres in the US.
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.”
According to J&J MedTech, its Varipulse Platform enables accurate and safe ablation through precise energy delivery and real-time visualisation of catheter positioning.
It facilitates minimal- to zero-fluoro workflow through easy integration with the intracardiac echocardiography (ICE) ultrasound portfolio providing real-time imaging.
Building on its tissue proximity indication and lesion tagging features, the platform provides electrophysiologists with feedback, supporting lesion durability and long-term outcomes.
Also, the platform enables a single transseptal zero exchange workflow for effective procedures to address both routine and complex AFib ablations, said J&J MedTech.
In addition to the Varipulse, J&J MedTech is developing a suite of PFA technologies, including the Dual Energy THERMOCOOL SMARTOUCH SF, and OMNYPULSE Catheters.
Dual Energy THERMOCOOL is an investigational device, currently studied in delivering both radiofrequency and PF energy.
OMNYPULSE is a large tip 12mm focal catheter that features contact force sensing and a TRUEref reference electrode.
Furthermore, the Varipulse Platform is currently approved in the US, Europe, Japan, and Canada, and has been used to treat more than 1,000 patients worldwide.
