Atrial fibrillation (AFib) device maker CardioFocus (Marlborough, MA) has presented positive results from its confirmatory study evaluating its HeartLight X3 System for the treatment of AFib. The results were presented during the Heart Rhythm Society's 40th Annual Scientific Sessions on May 10, 2019, in San Francisco, CA.
The HeartLight X3 System is a third-generation AFib ablation technology, building upon the advanced features of the company's HeartLight endoscopic ablation system, which 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's RAPID mode leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician, resulting in consistently reduced procedure times.
Petr Neužil, MD, PhD, Head of the Department of Cardiology at Na Homolce Hospital (NHH) in Prague, Czech Republic, and the trial's lead investigator, outlined the findings during a presentation titled, "Performance of a 3rd Generation Visually-Guided Laser Balloon for Pulmonary Vein Isolation: Results of the X3 Study." In the evaluation of 60 patients, the HeartLight X3 System consistently achieved very rapid PVI, in as few as three minutes for a single vein.
Key findings of the study included:
- HeartLight X3 procedure times were more than 90 minutes shorter than with the first-generation HeartLight System1—procedures can routinely be completed in one hour;2
- HeartLight X3 was able to isolate pulmonary veins in as fast as 3 min.;
- HeartLight X3 demonstrated comparable acute safety and efficacy to the first-generation HeartLight System;
- Ninety-nine percent of pulmonary veins were isolated acutely with the HeartLight X3 System; and
- Fluoroscopy times with HeartLight X3 were under 7 min. per procedure, substantially lower than with the first-generation HeartLight System.
The HeartLight X3 System is only approved for use in Europe and is not available for sale in the U.S.
1. S. R. Dukkipati et al., J. Am. Coll. Cardiol., 66, 12, 1350-1360 (Sep. 22, 2015).
2. P. Neužil et al., "Performance of a 3rd Generation Visually-Guided Laser Balloon Catheter for Pulmonary Vein Isolation: Results of the X3 Study," HRS 2019 (May 10, 2019).
For more information, please visit cardiofocus.com.