The newly approved platform offers an integrated approach for treating atrial fibrillation, combining pulsed field ablation with 3D mapping.

Summary: The FDA has approved Johnson & Johnson MedTech’s Varipulse Platform, a single-device solution that combines pulsed field ablation therapy and advanced mapping for treating drug-refractory paroxysmal atrial fibrillation. Designed for integration with the Carto 3 System, the platform combines pulsed field ablation therapy with advanced 3D mapping to improve the precision and efficiency of catheter ablation procedures. Backed by data from the admIRE study, the Varipulse Platform aims to provide electrophysiologists with enhanced imaging, accurate energy delivery, and a streamlined, minimally invasive workflow, potentially reducing procedure times and fluoroscopy use.

Key Takeaways:

  • Integrated Mapping and Ablation: The Varipulse Platform combines pulsed field ablation with the Carto 3 System’s 3D mapping, providing precise energy delivery and real-time catheter positioning for improved procedure accuracy.
  • Supported by Positive Clinical Data: In the admIRE study, 100% of patients achieved procedural success, with minimal adverse events and a significant portion of procedures performed without fluoroscopy.
  • Efficiency in Atrial Fibrillation Treatment: The platform’s integrated features aim to enable a faster, more predictable workflow, potentially benefiting both patients and electrophysiologists by reducing procedure time and enhancing treatment confidence.

The US Food & Drug Administration (FDA) has approved Johnson & Johnson MedTech’s Varipulse Platform for the treatment of drug-refractory paroxysmal atrial fibrillation.

The Varipulse Platform is designed to enable atrial fibrillation treatment with a single device that combines pulsed field ablation therapy and advanced mapping with the Carto 3 System, a 3D electroanatomical cardiac mapping system. 

Developed for integration with Carto, the Varipulse Platform enables:

  • The accuracy and safety of ablation procedures through precise energy delivery and real-time visualization of catheter positioning2
  • Minimal- to zero-fluoro workflow through seamless integration with the intracardiac echocardiography ultrasound portfolio providing real-time imaging3,4,5 
  • Confidence in treatment delivered through tissue proximity indication and lesion tagging, providing electrophysiologists with feedback that has proven to be critical for lesion durability and long-term outcomes
  • A single transseptal zero exchange workflow for an efficient and predictable procedure
  • A comprehensive solution to address both routine and complex atrial fibrillation ablations2

“We have learned that with [pulsed field ablation] technology, mapping integration is critically important for electrophysiologists to ‘see’ inside the heart and deliver pulsed field energy with accuracy,” says Luigi Di Biase, MD, PhD, FACC, FHRS, system director electrophysiology at Montefiore Health System and professor of medicine (cardiology) at Albert Einstein College of Medicine at Montefiore Hospital, in a release. “With today’s approval, electrophysiologists will have the ability to use an integrated mapping system—Carto—for [pulsed field ablation] procedures, enabling a singular, versatile workflow, that could reduce procedure time, potentially driving positive results for patients.”

Clinical Trial Data

The approval is supported by data from the admIRE study, a prospective, multi-center, non-randomized trial. Twelve-month outcome data from the pivotal phase of the admIRE study were published in Circulation. 

Among 291 patients across 30 healthcare centers in the US, 100% achieved acute procedural success, including 98% with first-pass isolation recorded per vein.2 85% achieved peak primary effectiveness when 73-96 applications were applied per vein (n=85), showed minimal adverse events (2.9%), and 25% of procedures were performed without fluoroscopy, likely attributable to integration with the Carto 3 System.2

[RELATED: Pulsed Field Ablation Safe for Atrial Fibrillation Patients]

“With this approval, we are excited to bring the Varipulse Platform to electrophysiologists and patients in the US, where [atrial fibrillation] impacts nearly eight million people,” says Jasmina Brooks, president of electrophysiology at Johnson & Johnson MedTech, in a release.6 “As the only [pulsed field ablation] 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 [atrial fibrillation] procedures with an intuitive and reproducible workflow, and minimal-to-no fluoroscopy.”

Atrial Fibrillation Affecting Millions

Atrial fibrillation is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and more than 50 million people worldwide.6 Approximately 1 in 4 adults over the age of 40 are at risk for developing atrial fibrillation.7 Despite these projections, about one-third of patients with atrial fibrillation are not aware they have the condition, and atrial fibrillation often goes unrecognized until the onset of complications.8,9 Catheter ablation is a safe and effective procedure when drugs don’t work to help restore the heart’s incorrect electrical signals, which cause an abnormal heart rhythm.10

“With a growing prevalence of atrial fibrillation around the world, innovative solutions are critical in expanding options for patients and helping electrophysiologists treat [atrial fibrillation] effectively and efficiently,” says Andrea Natale, MD, executive medical director at Texas Cardiac Arrythmia Institute, St. David’s Medical Center, in a 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.”

In addition to the Varipulse Platform, Johnson & Johnson MedTech is developing a suite of pulse field ablation technologies, including the investigational Dual Energy Thermocool Smartouch SF catheter—which is being studied to deliver both radiofrequency and pulsed field energy, and the OMnypulse catheter—a large-tip, 12 mm focal catheter with contact force sensing and a TRUEref reference electrode. 

Photo caption: The Varipulse Platform is now approved by the US Food and Drug Administration for electrophysiologists to use in catheter ablation procedures for the treatment of paroxysmal atrial fibrillation.

Photo credit: Johnson & Johnson MedTech

References

  1. Di Biase L, Zou F, Lin AN, et al. Feasibility of three-dimensional artificial intelligence algorithm integration with intracardiac echocardiography for left atrial imaging during atrial fibrillation catheter ablation. Europace. 2023 Aug 2;25(9):euad211.
  2. 2 Reddy, V. Y. (2024). Pulsed field ablation to treat paroxysmal atrial fibrillation: Safety and effectiveness in the admire pivotal trial. Circulation. 150(15). 
  3. Debreceni D, Janosi K, Bocz B, et al. Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis. Front.
  4. 4 Rajendra A, Hunter TD, Morales GX, et al. Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial
  5. Tahin T, Riba A, Nemeth B, et al. Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures. BMC Cardiovasc Disord;21(1):407.
  6. Mensah, G, Fuster, V, Murray, C. et al. Global burden of cardiovascular diseases and risks, 1990-2022. J Am Coll Cardiol. 2023 Dec, 82(25); 2350–2473.
  7. Staerk, et al. 2018 Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ. 2018;361:k1453
  8. Dilaveris PE, Kennedy HL. Silent atrial fibrillation: epidemiology, diagnosis, and clinical impact. Clin Cardiol. 2017;40:413–418.
  9. Benjamin EJ, Go AS, Desvigne-Nickens P et al. Research priorities in atrial fibrillation screening: a report from a National Heart, Lung, and Blood Institute virtual workshop. Circulation.
  10. Natale, A. Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology. 2014;64(7),647–56.