MARLBOROUGH, Mass., May 9, 2018 /PRNewswire/ -- CardioFocus, Inc., a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF), today announced a successful live case featuring its breakthrough HeartLight X3 System during the annual Prague Workshop on Catheter Ablation.
Building upon the advanced features of the current HeartLight Endoscopic Ablation System - direct tissue visualization, titratable laser energy, and compliant balloon technology - HeartLight X3 is designed to deliver rapid, continuous, 360-degree lesions, potentially making it the ultimate pulmonary vein isolation (PVI) tool for AF. The system offers a new "RAPID mode". This new mode of operation leverages a precise motor control system that enables uninterrupted, high-speed lesion creation.
The procedure, broadcast live during the workshop, demonstrated the breakthrough potential of the HeartLight X3 system. Successful PVI was achieved with a total energy delivery time of under 20 minutes. Performed by Petr Neužil, MD, PhD, Head of the Department of Cardiology at Na Homolce Hospital in Prague, Czech Republic and Vivek Y. Reddy, MD, Director of Cardiac Electrophysiology and Helmsley Trust Professor of Medicine at The Icahn School of Medicine at Mount Sinai, the case was part of the ongoing clinical evaluation of the HeartLight X3 System.
"The HeartLight X3 System is demonstrating an unprecedented combination of flexibility and speed," said Prof. Neužil "The HeartLight Excalibur Balloon™ enables wide areas of tissue contact outside of the pulmonary veins, allowing for the system's new RAPID mode to create never-seen-before circumferential, transmural lesion sets. RAPID mode allows for titratable, high-power energy delivery that enables fast ablations. The HeartLight X3 System truly holds the potential to be a breakthrough technology in the AF ablation space."
More than 33 million patients worldwide suffer from AF.1 AF, the most common type of cardiac rhythm disorder, prevents blood from being pumped efficiently, which can lead to stroke, weakness, breathlessness, fainting, and a significant reduction in quality of life. PVI with the HeartLight X3 System utilizes laser energy to create lines of scar tissue to block abnormal electrical pathways that cause AF.
The clinical evaluation of the HeartLight X3 System is planned to continue throughout 2018, with regulatory submissions to occur thereafter.
"CardioFocus is dedicated to continuous advancement of its leading AF treatment platform, the HeartLight Endoscopic Ablation System," said Burke T. Barrett, Chief Operating Officer at CardioFocus. "Prof. Neužil and Prof. Reddy demonstrated the remarkable potential of the HeartLight X3 System during the Prague Workshop and I am thrilled with the progress we are making with the ongoing clinical evaluation. We look forward to continuing the study and subsequently establishing our plans for commercial introduction of the HeartLight X3 System."
The HeartLight X3 System is investigational and not available for sale.
About CardioFocus, Inc.
Headquartered in Marlborough, Mass., CardioFocus Inc. is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as Atrial Fibrillation (AF). The company's first product, the HeartLight® Endoscopic Ablation System is a revolutionary catheter ablation technology designed for the treatment of AF, the most common heart arrhythmia. The device received CE Mark in 2009, U.S. FDA approval in April 2016 and Japan PMDA approval in July 2017. More than 4,500 patients with AF have been successfully treated with the system. For more information, visit www.cardiofocus.com.
1 Chugh SS, Havmoeller R, Narayanan K, et al.; Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47.
SOURCE CardioFocus, Inc.