FDA Approves Johnson & Johnson's Varipulse for Drug-Resistant Paroxysmal Atrial Fibrillation

The FDA has approved Johnson & Johnson查看公司主页’s Varipulse (搜索)搜索该药品 Pulsed Field Ablation (搜索)搜索该靶点 (PFA) Platform for the treatment of drug-resistant paroxysmal atrial fibrillation (搜索)搜索该疾病 (AFib (搜索)搜索该疾病). 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 (搜索)搜索该药品 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 (搜索)搜索该药品 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查看公司主页 MedTech, commented, “With this approval, we are excited to bring the VARIPULSE (搜索)搜索该药品 Platform to electrophysiologists and patients in the US, where AFib (搜索)搜索该疾病 impacts nearly eight million people. As the only PFA platform uniquely designed for seamless integration with the CARTO 3 (搜索)搜索该药品 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 (搜索)搜索该疾病 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查看公司主页 reports that AFib (搜索)搜索该疾病 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 (搜索)搜索该疾病 around the world, innovative solutions are critical in expanding options for patients and helping electrophysiologists treat AFib (搜索)搜索该疾病 effectively and efficiently. The VARIPULSE (搜索)搜索该药品 Platform enables efficient procedures with a favorable safety profile, allowing me to treat more patients and get them back to their normal lives.”