CardioFocus (Marlborough, MA), a medical device maker dedicated to advancing ablation treatment for atrial fibrillation (AF; a cardiac rhythm disorder), has completed enrollment in a trial to evaluate its next-generation HeartLight X3 endoscopic ablation system.
A total of 60 patients have been treated in the confirmatory trial with a one-month follow up. The trial will evaluate time, safety, and acute outcomes using the system in the treatment of AF as pivotal endpoints. Pulmonary vein isolation (PVI) with the system utilizes laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AF. Throughout the trial, the system consistently demonstrated short procedure times and achieved very rapid PVI, in as few as three minutes for a single vein.
Building upon the advanced features of the current system, including direct tissue visualization, titratable laser energy, and compliant balloon technology, the next-generation version is designed to deliver quick, continuous, circumferential lesions.
Data from the trial are expected to be used to obtain regulatory approvals, with European CE Mark approval expected in mid-2019.
For more information, please visit www.cardiofocus.com.