On November 7, 2024, the US Food and Drug Administration (FDA) approved the Varipulse pulsed-field ablation (PFA) system for treating drug-refractory paroxysmal atrial fibrillation (AF), marking a significant advancement in AF treatment within the U.S.
The Varipulse platform is uniquely integrated with the Carto 3 electroanatomical mapping system, allowing real-time, nonfluoroscopic procedural guidance and lesion indexing. The admIRE trial, which supported this FDA approval, involved 277 patients across 30 U.S. centers, achieving 100% pulmonary vein isolation and 97.5% first-pass isolation.
The trial's primary safety endpoint included a composite of potential complications, such as device- or procedure-related death and major vascular access complications, occurring in 2.9% of patients, thus meeting the prespecified performance goal. Within the past year, two other PFA systems, Farapulse and PulseSelect, have also received FDA approval.
PFA technology differs from conventional thermal ablation by delivering high-power electrical pulses that puncture cell membranes of cardiomyocytes. This electroporation method is considered safer than radiofrequency or cryoballoon ablation as it specifically targets myocardial tissue, minimizing damage to surrounding structures like the esophagus and phrenic nerve.
The VARIPULSE™ Platform combines PFA therapy and advanced mapping with the CARTO™ 3 System, which is the world's leading 3D electroanatomical cardiac mapping system. The platform enables precise energy delivery, minimal- to zero-fluoro workflow through intracardiac echocardiography (ICE), and tissue proximity indication for durable lesions and long-term outcomes.
A leading electrophysiologist highlighted the importance of mapping integration with PFA technology for accurate energy delivery, potentially reducing procedure time and benefiting patient outcomes. The admIRE study demonstrated high procedural success, with 85% peak effectiveness and minimal adverse events (2.9%), with some procedures performed without fluoroscopy.
A senior representative from Johnson & Johnson MedTech expressed excitement over the platform’s introduction in the U.S., emphasizing its unique integration with CARTO™ 3 and its potential in efficient and safe AF procedures for 8 million affected Americans.
As the most common cardiac arrhythmia, AFib affects over 50 million people worldwide. With an aging population, the demand for innovative solutions is increasing. The VARIPULSE™ Platform’s efficiency and safety profile enable electrophysiologists to treat more patients and improve their quality of life.
Johnson & Johnson MedTech’s commitment to PFA technology extends beyond VARIPULSE™. It is developing the Dual Energy THERMOCOOL SMARTOUCH™ SF Catheter and the OMNYPULSE™ Catheter, innovative tools designed for radiofrequency and pulsed-field energy delivery. These advancements reflect the company's dedication to providing advanced cardiovascular solutions and addressing unmet needs in conditions like heart failure, coronary artery disease, stroke, and AFib.
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