CardioFocus Completes Enrollment in HeartLight® X3 Trial

New Ablation System for Atrial Fibrillation Demonstrates Rapid Pulmonary Vein Isolation in as Fast as Three Minutes

MARLBOROUGH, MA – CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced completed enrollment in a trial to evaluate its next-generation HeartLight^® X3 Endoscopic Ablation System.

A total of 60 patients have been treated in this pivotal confirmatory trial with a one-month follow up. The trial will evaluate time, safety and acute outcomes using the HeartLight X3 System in the treatment of AFib as pivotal endpoints. Pulmonary Vein Isolation (PVI) with the HeartLight X3 System utilizes laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib, the most common type of cardiac rhythm disorder.¹ Throughout the trial, the HeartLight X3 System consistently demonstrated short procedure times and achieved very rapid PVI, in as few as three minutes for a single vein.

Building upon the advanced features of the current HeartLight Endoscopic Ablation System – direct tissue visualization, titratable laser energy, and compliant balloon technology – the HeartLight X3 System is designed to deliver quick, continuous, circumferential lesions, potentially making it the ultimate PVI tool for AFib. The system's unique RAPID mode leverages a precise motor control system that enables uninterrupted, high-speed lesion creation under direct control of the physician.

"With the potential to deliver all ablations in 15 to 20 minutes, the speed and feature set offered by the HeartLight X3 System is unprecedented," said Boris Schmidt, MD an investigator in the trial at Cardiovascular Center Bethanien in Frankfurt, Germany. "The HeartLight X3 System will give us the ability to treat patients more efficiently than ever before."

"The titratable laser energy, with the convenience of a one-shot approach, give the HeartLight X3 System the potential to be a breakthrough technology in the AFib ablation space," said Petr Neužil, MD, PhD, Head of the Department of Cardiology at Na Homolce Hospital in Prague, Czech Republic. "Those unique features coupled with the continuous lesions made in RAPID mode and decreased ablation time allow for unprecedented performance."

"CardioFocus is dedicated to continuous advancement of its leading AFib treatment platform, the HeartLight Endoscopic Ablation System," said Burke T. Barrett, President and Chief Operating Officer at CardioFocus. "The results we have seen with the HeartLight X3 System are very encouraging. The outcomes from this pivotal confirmatory trial will add to the mounting body of evidence to support this advanced system."

Data from the trial are expected to be used to obtain regulatory approvals, with European CE Mark expected in mid-2019.

The HeartLight X3 System is an investigational device and not available for sale.

About CardioFocus, Inc.

CardioFocus is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AFib), the most common heart arrhythmia. The company's FDA-approved HeartLight Endoscopic Ablation System has successfully treated more than 5,000 patients in the United States, Europe and Japan. In 2018, the company introduced the next-generation Excalibur Balloon™, the first FDA-approved ultra-compliant balloon indicated for AFib ablation. Excalibur leverages the proven universal balloon design of the company's HeartLight System and introduces an advanced feature set that optimizes the speed and magnitude of target tissue contact during AFib ablation procedures. The HeartLight System with the Excalibur Balloon is a revolutionary catheter ablation technology that along with direct visualization and titratable laser energy, represents a new standard for AFib ablation. CardioFocus is headquartered in Marlborough, MA. For more information, visit www.CardioFocus.com.

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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.