EU nod for endoscopic ablation systemJune 9, 2019
HeartLight X3 Endoscopic Ablation System has received European CE Mark approval for ablation treatment for atrial fibrillation.
HeartLight X3 Endoscopic Ablation System is a third-generation technology building upon the advanced features of the HeartLight Endoscopic Ablation System, which performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib.
Using direct tissue visualization, titratable laser energy, and compliant balloon technology, the HeartLight X3 System’s unique RAPID mode leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under the direct control of the physician resulting in consistently reduced procedure times.
In the pivotal confirmatory evaluation of 60 patients, the HeartLight X3 System consistently achieved very rapid PVI, in as few as three minutes for a single vein. The trial also found that the System has the potential to complete all required ablations in less than 20 minutes.