May 17, 2018 — Medical device manufacturer CardioFocus Inc. announced a successful live case featuring its HeartLight X3 System during the annual Prague Workshop on Catheter Ablation, April 21-24 in Prague, Czech Republic.
HeartLight X3 is designed to deliver rapid, continuous, 360-degree lesions for pulmonary vein isolation (PVI) to treat atrial fibrillation. The system does so by building upon the advanced features of the current HeartLight Endoscopic Ablation System — direct tissue visualization, titratable laser energy and compliant balloon technology. The system offers a new "RAPID mode" that leverages a precise motor control system to enable uninterrupted, high-speed lesion creation.
The procedure, broadcast live during the workshop, demonstrated the potential of the HeartLight X3 system. Successful PVI was achieved with a total energy delivery time of under 20 minutes. The case was performed by Petr Neužil, M.D., Ph.D., head of the Department of Cardiology at Na Homolce Hospital in Prague, Czech Republic, and Vivek Y. Reddy, M.D., director of cardiac electrophysiology and Helmsley Trust Professor of Medicine at The Icahn School of Medicine at Mount Sinai. It 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 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 The most common type of cardiac rhythm disorder, AF 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.
The HeartLight X3 System is investigational and not available for sale.
For more information: 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.