FDA Approves Updated VARIPULSE Platform Irrigation Flow Rate for Heart Disease

The US Food and Drug Administration (FDA) has approved an update to the VARIPULSE Platform’s irrigation flow rate, which is designed to optimize irrigation and support consistent successful operations with low adverse event rates.¹

Announced on July 14, 2025, by parent company Johnson & Johnson MedTech, the approval follows the significant milestone of >10,000 VARIPULSE procedures across all approved countries. The platform has also maintained a neurovascular adverse event rate of <.5% - although the release notes this statistic is calculated from internal customer reported data/complaints rather than a prospective clinical investigation. The rate reported is preliminary and pending publication.¹

More than 8 million people in the US and 50 million globally experience atrial fibrillation; 1 in 4 adults ≥40 years of age are at risk of development. However, 1 in 3 are unaware of the condition. Catheter ablation is a safe and effective method of restoring incorrect electrical signals in the heart when traditional therapies are incapable of generating change.³

“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. “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.”²

The VARIPULSE device is a Pulsed Field Ablation (PFA) system which was initially approved for drug refractory paroxysmal atrial fibrillation on November 7, 2024. It combines PFA therapy with the CARTO 3 system, the world’s leading 3D electroanatomical cardiac mapping system. The device provides real-time visualization of catheter positioning while delivering treatment confidence through tissue proximity indication and lesion tagging.²

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.³

The VARIPULSE Platform’s initial approval in 2024 was based on 12-month outcome data from the prospective, non-randomized, multi-center admIRE trial, which consisted of 291 patients from 30 US healthcare centers. By week 12, all patients achieved acute procedural success, including 98% with first-pass isolation recorded per vein. Roughly 85% of patients reached peak primary effectiveness when 73-96 applications were given per vein with few adverse events observed.³

“By learning from real-world experience and working closely with clinicians, we are continuously enhancing our technologies to improve patient care,” said Michael Bodner, company group chair, electrophysiology and neurovascular, Johnson & Johnson MedTech. “This update to the VARIPULSE Platform reflects our ongoing commitment to lead the evolution of PFA through meaningful, data-driven improvements that advance product performance and build procedural confidence.”¹

The Platform includes the VARIPULSE Catheter, TRUPULSE Generator, and CARTO 3D Mapping System VARIPULSE Software. It is available for use in the US and several other nations including Europe, China, and Canada.²

References

1. Johnson & Johnson Receives FDA Approval for Updated VARIPULSE Platform Irrigation Rate. J&J MedTech. July 14, 2025. Accessed July 14, 2025. https://www.jnjmedtech.com/en-US/news-events/johnson-johnson-receives-fda-approval-updated-varipulse-platform-irrigation-rate

2. MedTech J & J. Johnson & Johnson Medtech receives FDA approval for the VARIPULSETM pulsed field ablation platform for the treatment of atrial fibrillation. PR Newswire. November 7, 2024. Accessed July 14, 2025. 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

3. Iapoce C. FDA Approves VARIPULSE Platform for Treatment of Atrial Fibrillation. HCPLive. November 7, 2024. Accessed July 14, 2025. https://www.hcplive.com/view/fda-approves-varipulse-platform-for-treatment-of-atrial-fibrillation