FDA Approves Johnson & Johnson’s VARIPULSE Pulsed Field Ablation Platform for AFib

Johnson & Johnson MedTech announced that the U.S. Food and Drug Administration (FDA) has approved its VARIPULSE Platform for treating drug-refractory paroxysmal atrial fibrillation (AFib). This approval is based on findings from the admIRE clinical trial, which reported that 100% of patients achieved acute procedural success, with 98% achieving first-pass isolation per vein.

The VARIPULSE Platform offers a single-device solution that combines pulsed field ablation (PFA) with advanced mapping capabilities through the CARTO 3 System, a 3D electroanatomical cardiac mapping technology. Johnson & Johnson highlighted that VARIPULSE is the only PFA system in the U.S. fully integrated with CARTO 3.

Dr. Luigi Di Biase, system director of electrophysiology at Montefiore Health System and professor of cardiology at Albert Einstein College of Medicine, commented on the approval in a statement, saying that “mapping integration is critically important for electrophysiologists to ‘see’ inside the heart and deliver pulsed field energy with accuracy.” He noted that the integration of CARTO with the PFA procedures will allow for a streamlined workflow, potentially reducing procedure times and improving patient outcomes.

The admIRE study also showed that 85% of participants achieved peak primary effectiveness when 73 to 96 applications were used per vein. Jasmina Brooks, president of electrophysiology at Johnson & Johnson MedTech, expressed enthusiasm for the approval, stating that the VARIPULSE Platform could significantly benefit the approximately eight million people in the U.S. affected by AFib. She emphasized that the platform’s design allows for a seamless integration with the CARTO 3 System, creating a safe and efficient workflow with minimal fluoroscopy.

The admIRE trial was a prospective, multi-center, single-arm study, divided into a pilot phase that assessed initial safety and effectiveness and a pivotal phase to measure outcomes against pre-set performance goals. The primary endpoint included the incidence of early-onset adverse events.

In February, Biosense Webster, a Johnson & Johnson MedTech subsidiary, presented additional admIRE trial data at the AF Symposium, reporting no procedure- or device-related primary adverse events in the pilot phase. Dr. David Newton, a clinical cardiac electrophysiologist at Memorial Health University Medical Center in Savannah, Georgia, remarked that the pilot results were promising, indicating that VARIPULSE could become a vital tool for electrophysiologists performing catheter ablations for AFib treatment.