The FDA has approved Johnson & Johnson’s Varipulse Pulsed Field Ablation (PFA) Platform for the treatment of drug-resistant paroxysmal atrial fibrillation (AFib). This approval marks a significant advancement in the treatment of AFib, a condition affecting millions in the United States. The platform integrates PFA therapy with the CARTO 3 system, offering a single-device workflow with minimal fluoroscopy requirements, real-time imaging, and lesion tagging, which helps improve ablation accuracy and long-term outcomes.
Clinical Trial Data
The approval was supported by the admIRE study, a prospective, multi-center, non-randomized trial involving 291 patients across 30 healthcare centers in the United States. The study demonstrated a 100% procedural success rate. Twelve-month outcome data from the pivotal phase of the admIRE study were published in Circulation.
Results from the admIRE trial indicated that 98% of patients achieved first-pass isolation recorded per vein, and 85% achieved peak primary effectiveness with 73-96 applications per vein. The rate of adverse events (AEs) was low, with only 2.9% of patients reporting an AE. Notably, 25% of procedures were performed without fluoroscopy, likely due to integration with the CARTO 3 system.
Expert Commentary
Luigi Di Biase, MD, PhD, FACC, FHRS, system director, electrophysiology, Montefiore Health System, professor of medicine (Cardiology), Albert Einstein College of Medicine at Montefiore Hospital, stated, “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. 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.”
Impact on AFib Treatment
Jasmina Brooks, president, Electrophysiology, Johnson & Johnson MedTech, commented, “With this approval, we are excited to bring the VARIPULSE Platform to electrophysiologists and patients in the US, where AFib impacts nearly eight million people. 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.”
Atrial Fibrillation: A Growing Concern
According to the American Heart Association, the prevalence of AFib has increased threefold over the last 50 years, with an estimated prevalence of around 46.3 million individuals in 2016. The lifetime risk is estimated to be around one in four in white men and women older than 40 years of age, with those numbers increasing to one in three a decade later. Currently, it is estimated that three million to six million people in the United States are living with AFib.
Johnson & Johnson reports that AFib is the most common type of cardiac arrhythmia, affecting more than eight million people in the United States and 50 million globally. Approximately one-third of patients with AFib are unaware they have the condition, and it often goes unrecognized until the onset of complications.
Andrea Natale, MD, executive medical director, Texas Cardiac Arrythmia Institute, St. David’s Medical Center, added, “With a growing prevalence of atrial fibrillation around the world, innovative solutions are critical in expanding options for patients and helping electrophysiologists treat AFib effectively and efficiently. 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.”
