CardioFocus Announces Initiation of HeartLight® X3 Clinical Evaluation

Breakthrough, Next-Generation Technology for Atrial Fibrillation Demonstrates High Speed Isolation of Pulmonary Veins

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Feb 26, 2018, 10:00 ET

MARLBOROUGH, Mass., Feb. 26, 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 the initiation of a clinical evaluation of the new HeartLight X3 System for the treatment of AF.

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 initial cases were completed at Na Homolce Hospital in Prague, Czech Republic and performed by Petr Neužil, MD, PhD, Head of the Department of Cardiology, and his team.

"The potential reduction in procedure times combined with a better assurance of gap-free lesion sets will help this device change the way PVI is performed," said Prof. Neužil. "I'm excited to be able to offer this breakthrough approach to my patients during this clinical evaluation phase."

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 works by using 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 committed to establishing a new benchmark in the field of PVI by delivering leading technologies that provide positive patient outcomes and offer physicians efficient and effective treatment options," said Burke T. Barrett, Chief Operating Officer at CardioFocus. "We are encouraged by the initial positive feedback we have received on the HeartLight X3 System from Prof. Neužil and look forward to expanding this important clinical evaluation to additional European study sites and patients. Compared to our current system, HeartLight X3 holds the potential to accelerate the speed of pulmonary vein isolation threefold. This could lead to extraordinary decreases in procedure time. We are excited to continue to evaluate the system's performance as part of this clinical evaluation."

About Na Homolce Hospital

Accredited by Joint Commission International (JCI), Na Homolce Hospital is among the top hospitals in Europe and focuses on the comprehensive treatment of cardiovascular and neurological/neurosurgical diseases. Within the cardiovascular specialization, Na Homolce offers the largest range of modern and clinically verified diagnostics and treatments, including robotic cardiac and vascular surgery, minimally-invasive techniques and conservative treatment options. Its cardiology centers treat cardiac rhythm disorders, chronic heart failure, congenital heart defects, aortic disease, and valvular heart disease. For more information visit www.homolka.cz/en-CZ/home

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.

Media Contact:
Helen Winkler
Phone: 949.606.2008
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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.