Johnson & Johnson MedTech today announced FDA approval of the VARIPULSE Platform for the treatment of drug refractory paroxysmal Atrial Fibrillation (AFib).
The VARIPULSE Platform is designed to enable AFib treatment with a single device that combines PFA therapy and advanced mapping with the CARTO 3 System, a 3D electroanatomical cardiac mapping system. Strategically developed for full integration with CARTO, the VARIPULSE Platform enables:
- The accuracy and safety of ablation procedures through precise energy delivery and real-time visualization of catheter positioning
- Minimal- to zero-fluoro workflow through seamless integration with the intracardiac echocardiography (ICE) ultrasound portfolio providing real-time imaging
- Confidence in treatment delivered through tissue proximity indication and lesion tagging, providing electrophysiologists with feedback that has proven to be critical for lesion durability and long-term outcomes
- A single transseptal zero exchange workflow for an efficient and predictable procedure
- A comprehensive solution to seamlessly address both routine and complex AFib ablations
In addition to the VARIPULSE Platform, Johnson & Johnson MedTech is committed to developing a comprehensive suite of PFA technologies, including the investigational Dual Energy THERMOCOOL SMARTOUCH SF Catheter – which is being studied to deliver both radiofrequency and PF energy, and the OMNYPULSE Catheter – a large-tip, 12 mm focal catheter with contact force sensing and a TRUEref reference electrode.
The Dual Energy THERMOCOOL SMARTOUCH SF Catheter and the OMNYPULSE Catheter are investigational and not available for sale or distribution in any market.
