February 4, 2020
CardioFocus Makes PMA Supplement Submission to FDA for the HeartLight X3 Endoscopic Ablation System
February 4, 2020—CardioFocus, Inc. announced that it has submitted a premarket approval (PMA) supplement to the FDA for the company’s HeartLight X3 endoscopic ablation system to treat atrial fibrillation (AF). This supplement follows the original, approved PMA of the HeartLight endoscopic system.
The United States commercial launch of the HeartLight X3 system will immediately follow approval of the PMA supplement by the FDA. Currently not available for sale in the United States, the HeartLight X3 system is only approved for use in Europe.
According to the company, the HeartLight X3 system is a next-generation AF ablation technology that builds on the advanced features of the HeartLight endoscopic ablation system. The system performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AF.
Using direct tissue visualization, titratable laser energy, and compliant balloon technology, the HeartLight X3 system offers a unique Rapid mode. The Rapid mode leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician, resulting in significantly reduced procedure times. During the pivotal confirmatory study of 60 patients, the HeartLight X3 system achieved rapid PVI in as little as 3 minutes for a single vein, noted CardioFocus.