Johnson & Johnson (J&J) MedTech has secured FDA approval for its Varipulse pulsed field ablation (PFA) platform, designed for treating drug-refractory paroxysmal atrial fibrillation (AF). This approval marks a significant advancement in AF treatment, offering electrophysiologists a new tool that integrates PFA therapy with advanced mapping capabilities.
The Varipulse platform is engineered for seamless integration with the Carto 3 system, J&J MedTech's 3D electroanatomical cardiac mapping system. This integration facilitates precise energy delivery and real-time visualization of catheter positioning, enhancing the accuracy and safety of ablation procedures. According to J&J MedTech, the platform also supports minimal-to-zero fluoroscopy workflows through integration with intracardiac echocardiography (ICE) ultrasound, providing real-time imaging.
Clinical Evidence from the admIRE Study
The FDA's approval was supported by data from the admIRE study, a prospective, multicenter, non-randomized trial. The 12-month outcome data, published in Circulation, revealed that among 291 patients across 30 U.S. healthcare centers, 100% achieved acute procedural success, with 98% showing first-pass isolation per vein. The study also reported 85% peak primary effectiveness when 73–96 applications were applied per vein (n=85), minimal adverse events (2.9%), and 25% of procedures performed without fluoroscopy.
Integration with Carto 3 System
Luigi Di Biase from Montefiore Health System noted the importance of mapping integration for electrophysiologists to visualize the heart and accurately deliver pulsed field energy. The integration of Varipulse with the Carto 3 system enables a versatile workflow that could reduce procedure time and improve patient outcomes.
Comprehensive Solution for AF Ablation
The Varipulse platform offers several key features, including tissue proximity indication and lesion tagging, providing electrophysiologists with feedback critical for lesion durability and long-term outcomes. It also supports a single transseptal zero exchange workflow for efficient and predictable procedures, making it a comprehensive solution for both routine and complex AF ablations.
Future Developments
J&J MedTech is also developing a suite of PFA technologies, including the investigational dual-energy Thermocool Smarttouch Surroundflow (SF) catheter, which is being studied to deliver both radiofrequency and pulsed field energy, and the Omnypulse catheter, a large-tip, 12mm focal catheter with contact force sensing and a Trueref reference electrode.
Jasmina Brooks, president of Electrophysiology at J&J MedTech, expressed excitement about bringing the Varipulse platform to electrophysiologists and patients in the U.S., where AF impacts nearly eight million people. Andrea Natale from St David’s Medical Center added that the Varipulse platform enables efficient procedures with a favorable safety profile, allowing more patients to be treated effectively.
