FDA Approves VARIPULSE Platform for Treatment of Atrial Fibrillation

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved the VARIPULSE pulsed field ablation (PFA) platform for the treatment of drug-refractory paroxysmal atrial fibrillation (AF).¹

Announced by Johnson & Johnson MedTech, on November 7, 2024, the VARIPULSE platform is designed to allow AF treatment with one, single device that can combine PFA therapy and advanced mapping with the 3D electroanatomical cardiac mapping CARTO 3 System.

“With a growing prevalence of AF around the world, innovative solutions are critical in expanding options for patients and helping electrophysiologists treat AF effectively and efficiently,” said Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute, St. David’s Medical Center.¹ “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.”

More than 8 million people in the US, and 50 million worldwide, experience AF, with approximately 1 in 4 adults ≥40 years old at risk for development.² However, one-third of patients with AF are unaware of their condition and it can go undiagnosed until complications begin. Catheter ablation can safely and effectively restore the heart’s incorrect electrical signals when therapies fail.

The VARIPULSE platform, developed for full integration with the CARTO system, allows the accuracy and safety of ablation procedures through precise energy delivery and real-time visualization of catheter positioning.¹ The device enables minimal- to zero-fluoro workflow through integration with the intracardiac echocardiography (ICE) ultrasound profile, allowing for real-time imaging.

As treatment is delivered through tissue proximity and lesion tagging, electrophysiologists receive critical feedback for lesion durability and long-term outcomes with the platform. VARIPULSE could provide a comprehensive solution to address both routine and complex AF ablations, according to Johnson & Johnson MedTech.

Approval of the VARIPULSE PFA platform was awarded based on 12-month outcome data from the pivotal phase of the prospective, multi-center, non-randomized admIRE trial. Among 291 patients from 30 US healthcare centers, all (100%) achieved acute procedural success, including 98% with first-pass isolation recorded per vein.

Nearly 85% achieved peak primary effectiveness when 73–96 applications were applied per vein and demonstrated few adverse events (2.9%). Approximately one-quarter (25%) of procedures were performed without fluoroscopy, which the company attributed to integration with the CARTO 3 System.

Johnson & Johnson MedTech’s development suite of investigational PFA technologies includes the investigational Dual Energy THERMOCOOL SMARTOUCH SF Catheter for radiofrequency and PF energy, and the OMNYPULSE Catheter, a large-tip, 12 mm focal catheter with contact force sensing and a TRUEref reference electrode.

“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, System Director of Electrophysiology at Montefiore Health System.¹ “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.”

References

1. _{MedTech J& J. Johnson & Johnson Medtech receives FDA approval for the VARIPULSETM pulsed field ablation platform for the treatment of atrial fibrillation. PR Newswire: press release distribution, targeting, monitoring and marketing. November 7, 2024. Accessed November 7, 2024. https://www.prnewswire.com/news-releases/johnson--johnson-medtech-receives-fda-approval-for-the-varipulse-pulsed-field-ablation-platform-for-the-treatment-of-atrial-fibrillation-302298232.html.}
2. _{Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020;127(1):4-20. doi:10.1161/CIRCRESAHA.120.316340}