J&J MedTech Wins FDA Approval for VARIPULSE PFA Platform

Johnson & Johnson MedTech has earned U.S. Food and Drug Administration (FDA) approval for its VARIPULSE platform to treat drug refractory, paroxysmal atrial fibrillation (AFib).

VARIPULSE enables AFib treatment with one device that combines pulsed field ablation (PFA) therapy and advanced mapping with the CARTO 3 system, a 3D electroanatomical cardiac mapping system. According to J&J, VARIPULSE’s precise energy delivery and real-time catheter position visualization with CARTO 3 enable safety and accuracy in ablation procedures.

The company also said the platform offers minimal- to zero-fluoro workflow through integration with the intracardiac echocardiography (ICE) ultrasound portfolio. Tissue proximity indication and lesion tagging provide electrophysiologists with feedback that the company said has proven to be critical for lesion durability and long-term outcomes.

The VARIPULSE platform also boasts a single transseptal zero exchange workflow for an efficient and predictable procedure.

The approval was 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% achieved acute procedural success, including 98% with first-pass isolation recorded per vein. 85% achieved peak primary effectiveness when 73-96 applications were applied per vein (n=85), showed minimal adverse events (2.9%), and 25% of procedures were performed without fluoroscopy, likely attributable to integration with the CARTO 3 System.

“We have learned that with PFA technology, mapping integration is critically important for electrophysiologists to ‘see’ inside the heart and deliver pulsed field energy with accuracy,” explained Luigi Di Biase, MD, PhD, FACC, FHRS, System Director Electrophysiology at Montefiore Health System, Professor of Medicine (Cardiology) Albert Einstein College of Medicine at Montefiore Hospital.iv “With today’s approval, electrophysiologists will have the ability to use an integrated mapping system—CARTO—for PFA procedures, enabling a singular, versatile workflow, that could reduce procedure time, potentially driving positive results for patients.”

“With this approval, we are excited to bring the VARIPULSE Platform to electrophysiologists and patients in the U.S., where AFib impacts nearly eight million people,” added Jasmina Brooks, President, Electrophysiology, Johnson & Johnson MedTech. “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.”