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

Image Credit: Adobe Stock Images/Sun

The FDA has approved Johnson & Johnson’s (J&J) Varipulse Pulsed Field Ablation (PFA) Platform for the treatment of drug-resistant paroxysmal atrial fibrillation (AFib). The platform includes PFA therapy with the CARTO 3 system, a single-device workflow with minimal to zero fluoroscopy requirements, real-time imaging, and lesion tagging, which helps improve ablation accuracy and long-term outcomes, according to J&J. The approval was supported by the admIRE study, which showed a 100% procedural success rate.¹

“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,” said 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, in a press release. “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.”

The prospective, multi-center, non-randomized admIRE trial consisted of 291 patients across 30 healthcare centers in the United States. Twelve-month outcome data from the pivotal phase of the admIRE study were published in Circulation.

Other than the perfect procedural success rate, results found that 98% of patients achieved first-pass isolation recorded per vein and 85% achieved peak primary effectiveness when 73-96 applications were applied per vein. The rate of adverse events (AEs) was found to be low, with only 2.9% of patients reporting an AE. Twenty-five percent of procedures were performed without fluoroscopy2, likely attributable to integration with the CARTO 3 system.¹

“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,” said Jasmina Brooks, president, Electrophysiology, Johnson & Johnson MedTech, in the press release. “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.”

According to the American Heart Association, the prevalence of AFib increased 3-fold over the last 50 years, with an estimated prevalence of around 46.3 million individuals in 2016. Additionally, the lifetime risk was estimated to be around one in four in white men and women older than 40 years of age in 2004, with those numbers increasing to one in three a decade later. Today, it is estimated that anywhere from three million to six million people in the United States are currently living with AFib.²

According to J&J, AFib is the most common type of cardiac arrhythmia and affects more than eight million people in the United States and 50 million globally. Around one-thirdof patients with AFib are not aware they have the condition, and it often goes unrecognized until the onset of complications.¹

“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,” said Andrea Natale, MD, executive medical director, Texas Cardiac Arrythmia Institute, St. David’s Medical Center, in the press release. “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.”

References

1. Johnson & Johnson MedTech Receives FDA Approval for the VARIPULSE™ Pulsed Field Ablation Platform for the Treatment of Atrial Fibrillation. J&J. November 7, 2024. Accessed November 8, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-medtech-receives-fda-approval-for-the-varipulse-pulsed-field-ablation-platform-for-the-treatment-of-atrial-fibrillation

2. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. AHA. June 18, 2020. Accessed November 8, 2024. https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.120.316340