FDA Approves Johnson & Johnson’s VARIPULSE Pulsed Field Ablation Platform
The approval is based on results from the admIRE study, which showed 100% of atrial fibrillation patients achieved acute procedural success.
Johnson & Johnson MedTech has announced the FDA approval of its VARIPULSE Platform for the treatment of drug refractory paroxysmal atrial fibrillation (AFib). This approval is supported by results from the admIRE clinical trial, in which 100% of patients achieved acute procedural success, including 98% with first-pass isolation recorded per vein.1
The VARIPULSE Platform enables AFib treatment with a single device that combines pulsed field ablation (PFA) and advanced mapping with the CARTO 3 System, a 3D electroanatomical cardiac mapping system. According to Johnson & Johnson, VARIPULSE is the first and only PFA system in the US fully integrated with CARTO 3.
In a press release, Luigi Di Biase, MD, PhD, FACC, FHRS, system director electrophysiology at Montefiore Health System, Professor of Medicine (Cardiology) Albert Einstein College of Medicine at Montefiore Hospital said, “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—or PFA procedures, enabling a singular, versatile workflow, that could reduce procedure time, potentially driving positive results for patients.”
In addition to the perfect mark in acute procedural success, admIRE study results showed 85% of participants achieved peak primary effectiveness when 73-96 applications were applied per vein.
“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,” Jasmina Brooks, president, electrophysiology, Johnson & Johnson MedTech, added 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.”
The admIRE trial is a prospective, multi-center, single-arm study. It consisted of a pilot phase, which assessed initial safety and effectiveness, and a pivotal phase, which assessed pervious results against pre-specified performance goals. The primary endpoint included incidence of early onset primary adverse events.2
Earlier in February, Biosense Webster, part of Johnson & Johnson MedTech, shared late-breaking data from the admIRE trial. In addition to the results previously mentioned, there were no procedure or device-related primary adverse events reported in the pilot phase.
In an earlier press release, David Newton, MD, clinical cardiac electrophysiologist, Memorial Health University Medical Center, Savannah, Georgia said, “The results observed in the pilot phase of the admIRE study point to the promise of the VARIPULSE Platform in treating patients with paroxysmal AFib. These initial results are encouraging and demonstrate the potential for the VARIPULSE Platform to become a key component of the suite of tools electrophysiologists have at their disposal to perform catheter ablations.”
References
1. Johnson & Johnson MedTech Receives FDA Approval for the VARIPULSE™ Pulsed Field Ablation Platform for the Treatment of Atrial Fibrillation. News release. Johnson & Johnson. 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. Biosense Webster Presents Late-Breaking Data from inspIRE and admIRE Clinical Trials at AF Symposium. News release. Johnson & Johnson. February 2, 2024. Accessed November 8, 2024. https://www.jnj.com/media-center/press-releases/biosense-webster-presents-late-breaking-data-from-inspire-and-admire-clinical-trials-at-af-symposium
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