FDA Approves Varipulse Pulsed-Field Ablation System for AF

The US Food and Drug Administration has approved the Varipulse pulsed-field ablation (PFA) system for the treatment of drug-refractory paroxysmal atrial fibrillation (AF), device manufacturer Johnson & Johnson MedTech announced today.

The Varipulse platform, unlike other recently approved PFA systems, is fully integrated with the Carto 3 electroanatomical mapping system, which is also manufactured by Johnson & Johnson and provides real-time nonfluoroscopic procedural guidance and lesion indexing.

The FDA approval was based on results from the admIRE trial, a single-arm, investigational device exemption study conducted at 30 US centers. Among 277 patients with drug-refractory, symptomatic paroxysmal AF, pulmonary vein isolation was successful in 100% of cases, with first-pass isolation achieved in 97.5% of targeted veins.

The primary safety endpoint—a composite of device- or procedure-related death, major vascular access complications or bleeding, MI, pericarditis, heart block, permanent phrenic nerve paralysis, stroke, thromboembolism, TIA, pulmonary edema, or vagal nerve injury/gastroparesis within the first 7 days after ablation—occurred in 2.9% of patients, which achieved the prespecified performance goal.

Within the past 12 months, the FDA has approved two other PFA systems: Farapulse (Boston Scientific) and PulseSelect (Medtronic). Boston Scientific recently announced FDA approval a navigation-enabled ablation catheter and software module that could be used with their existing cardiac mapping technology.

Unlike conventional thermal ablation, PFA delivers high-power electrical pulses that puncture the cell membranes of cardiomyocytes. This electroporation approach is considered safer than radiofrequency or cryoballoon ablation because it is more specific for myocardial tissue, which is believed to limit damage to surrounding structures, such as the esophagus and phrenic nerve.