Johnson & Johnson receives US FDA Approval for the VARIPULSE pulsed field ablation platform

Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the U.S. 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, the world's leading 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.

The approval is supported by data from the admIRE study, a prospective, multi-center, non-randomized trial. Twelve-month outcome data from the pivotal phase of the admIRE study were published in Circulation. Among 291 patients across 30 healthcare centers in the U.S., 100 percent achieved acute procedural success, including 98 percent with first-pass isolation recorded per vein.2 85 percent achieved peak primary effectiveness when 73-96 applications were applied per vein (n=85), showed minimal adverse events (2.9 percent), and 25 percent of procedures were performed without fluoroscopy2, likely attributable to integration with the CARTO™ 3 System.