CardioFocus Gains FDA Clearance for Endoscopic Ablation System

The FDA granted marketing clearance for CardioFocus’ HeartLight X3 endoscopic ablation system for treatment of atrial fibrillation.

The system uses laser energy to create lines of scar tissue that block the abnormal electrical pathways that cause atrial fibrillation. The HeartLight X3 provides direct visualization of pulmonary veins, enabling physicians to create continuous lesions.

The company expects to launch the system in the U.S. this year.