The VARIPULSE Pulsed Field Ablation Platform.

The VARIPULSE platform including a variable loop catheter, TRUPULSE Generator, and CARTO 3 Mapping System VARIPULSE Service Pack Software, has been developed to deliver pulsed field ablation (PFA) in combination with the benefits of electroanatomical mapping. In preclinical studies, delivery of PFA using the VARIPULSE platform has been found to be safe and feasible with evidence of durable ablation lesions within the atria. Clinical studies have demonstrated the system to be safe and feasible to facilitate pulmonary vein isolation for paroxysmal atrial fibrillation ablation, without esophageal or phrenic nerve injury and low rates of arrhythmia recurrence at 12 months.