Johnson & Johnson has taken a step forward in cardiac arrhythmia treatment with the submission of its premarket approval application for the Varipulse pulsed field ablation (PFA) platform to the FDA. The submission is supported by data from the admIRE study, a prospective, multi-center trial aimed at assessing the safety and efficacy of Varipulse among U.S. patients with symptomatic drug-refractory paroxysmal AFib. This study, conducted in collaboration with leading medical institutions, revealed compelling outcomes, with 100% of patients achieving acute success from ablation procedures, demonstrating the platform’s efficacy in addressing the underlying electrical disturbances that characterize AFib. 80% of patients remained free from atrial arrhythmia recurrence at the one-year mark, highlighting the potential long-term benefits of Varipulse in improving patient outcomes.
The Varipulse platform comprises several integrated components, including the Varipulse catheter, a variable-loop multielectrode catheter designed for pulmonary vein isolation, the TruPulse generator, and the Carto 3 System Varipulse Software. One of the platform’s distinguishing features is its seamless integration with the Carto 3 System, a leading 3D cardiac mapping system. This integration allows electrophysiologists to visualize the heart’s anatomy in real-time, providing guidance during ablation procedures. The Carto 3 System also offers advanced features such as contact indicators and PF tagging mechanisms, further enhancing procedural efficiency and ensuring accurate lesion formation.
While competitors like Boston Scientific and Medtronic have already obtained FDA approval for their PFA devices, J&J’s focus on Carto integration outlines its commitment to advancing the standard of care in AFib treatment. The admIRE study, which formed the basis of the PMA submission, demonstrated not only the efficacy but also the safety of Varipulse. No procedure or device-related primary adverse events were reported in the study, emphasizing Varipulse’s favorable safety profile. The median procedure and fluoroscopy times were reduced, attributed to the integration with the Carto 3 System, thereby minimizing patient exposure to radiation and optimizing procedural outcomes.
J&J’s pursuit of FDA approval for Varipulse reflects its broader strategy to meet the evolving needs of electrophysiologists and their patients. With over 5,000 Carto systems deployed globally, J&J is well-positioned to leverage its expertise in cardiac ablation and mapping technology to drive Varipulse’s market adoption. The company is developing a range of catheters tailored to individual patient characteristics, enabling personalized treatment approaches. Despite the momentum behind PFA, J&J remains committed to radiofrequency ablation, recognizing its continued relevance in the management of cardiac arrhythmias.
J&J’s submission of Varipulse for FDA approval represents a milestone in the advancement of PFA technology. Backed by clinical evidence and enhanced by integration with the Carto 3 System, Varipulse holds promise as a valuable addition to the range of treatments for AFib. As the regulatory process unfolds, healthcare professionals can anticipate a new era of innovation in cardiac electrophysiology, ultimately benefiting patients worldwide.
