CardioFocus submits U.S. FDA PMA supplement for endoscopic ablation system

Medical device maker CardioFocus (Marlborough, MA), which is dedicated to advancing ablation treatment for atrial fibrillation (AFib), has submitted a premarket approval (PMA) supplement to the U.S. FDA for its HeartLight X3 endoscopic ablation system for the treatment of AFib. This supplement follows the original, approved PMA of the company's HeartLight endoscopic system. U.S. commercial launch of the HeartLight X3 system will immediately follow approval of the PMA supplement.

The HeartLight X3 system builds 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 RAPID mode that leverages a precise motor control system to enable 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 very rapid PVI in as few as three minutes for a single vein.  

Based on the company's initial interactions with the U.S. FDA, the company anticipates launching the HeartLight X3 system into the U.S. market in 2020, says Burke T. Barrett, CEO at CardioFocus.   

For more information, please visit cardiofocus.com.