CardioFocus announced they have submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of AFib.
This supplement follows the original, approved PMA of the HeartLight Endoscopic System. U.S. commercial launch of the HeartLight X3 System will immediately follow the approval of the PMA supplement.
The HeartLight X3 System is a next-generation AFib ablation technology, building upon 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 AFib. Using direct tissue visualization, titratable laser energy, and compliant balloon technology, the HeartLight X3 System offers a unique RAPID mode. 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 significantly reduced procedure times. During the pivotal confirmatory study of 60 patients, the HeartLight X3 System achieved very rapid PVI, in as few as three minutes for a single vein.
“The excitement surrounding the introduction of HeartLight X3 into the European market has been palpable,” said Burke T. Barrett, Chief Executive Officer at CardioFocus. “We have treated nearly 500 patients with the technology and the ability to deploy rapid, continuous laser energy circumferentially and outside of the pulmonary vein is compelling. The submission of this PMA supplement marks a tremendous milestone as we prepare to bring this breakthrough product to the U.S. Based on our initial interactions with FDA, we anticipate launching HeartLight X3 into the U.S. market this year.”