Johnson & Johnson MedTech has announced FDA approval for its VARIPULSE™ Pulsed Field Ablation (PFA) platform for the treatment of atrial fibrillation (AFib). This approval marks a significant advancement in AFib treatment, offering electrophysiologists a new tool that combines PFA therapy with the advanced CARTO™ 3 System, a leading 3D electroanatomical cardiac mapping system.
The VARIPULSE™ platform is designed to enhance the accuracy and safety of ablation procedures through precise energy delivery and real-time visualization of catheter positioning. Its integration with the CARTO™ 3 System allows for minimal-to-zero fluoroscopy workflows, utilizing intracardiac echocardiography (ICE) for real-time imaging. The platform also provides tissue proximity indication and lesion tagging, offering electrophysiologists critical feedback for lesion durability and long-term outcomes.
Clinical Trial Data and Outcomes
The FDA approval is supported by data from the admIRE study, a prospective, multi-center, non-randomized trial. The 12-month outcome data, published in Circulation, demonstrated that among 291 patients across 30 U.S. healthcare centers, 100% achieved acute procedural success, with 98% experiencing first-pass isolation per vein. Peak primary effectiveness was achieved in 85% of patients when 73-96 applications were applied per vein (n=85). The study also reported minimal adverse events (2.9%), and 25% of procedures were performed without fluoroscopy, likely due to the integration with the CARTO™ 3 System.
Expert Commentary
Luigi Di Biase, MD, PhD, FACC, FHRS, System Director Electrophysiology at Montefiore Health System, emphasized the importance of mapping integration with PFA technology. "With PFA technology, mapping integration is critically important for electrophysiologists to 'see' inside the heart and deliver pulsed field energy with accuracy," said Dr. Di Biase. "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."
Andrea Natale, M.D., Executive Medical Director, Texas Cardiac Arrythmia Institute, St. David's Medical Center, added, "The VARIPULSE Platform enables efficient procedures with a favorable safety profile, allowing me to treat more patients and get them back to their normal lives."
Addressing Atrial Fibrillation
AFib is the most common type of cardiac arrhythmia, affecting over 8 million people in the United States and more than 50 million worldwide. Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib. Catheter ablation is a safe and effective procedure used when drugs fail to restore the heart's correct electrical signals.
Johnson & Johnson's Commitment to PFA Technology
In addition to the VARIPULSE™ Platform, Johnson & Johnson MedTech is 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. These devices are currently investigational and not available for sale.
The VARIPULSE™ Platform is now approved for use in the United States, Europe, Japan, and Canada, and has been used in External Evaluations to treat more than 1,000 patients worldwide.
