CardioFocus Announces Impressive Results From Pivotal Confirmatory Study With The Breakthrough HeartLight® X3 System

Study Results Presented at the Heart Rhythm Society's 40th Annual Scientific Sessions

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May 10, 2019, 12:00 ET

MARLBOROUGH, Mass., May 10, 2019 /PRNewswire/ -- CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced the presentation of results from its pivotal confirmatory study evaluating the HeartLight X3 System for the treatment of AFib. The results, which demonstrated superior procedural times and impressive procedural outcomes, were presented during the Heart Rhythm Society's 40^th Annual Scientific Sessions on May 10, 2019 in San Francisco.

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 3^rd 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 pulmonary vein isolation (PVI), in as few as three minutes for a single vein.

The HeartLight X3 System is a third generation AFib ablation technology, building upon the advanced features of the HeartLight Endoscopic Ablation System, which performs 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 unique 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.

"Our trial results using the HeartLight X3 System were outstanding, with the study meeting all the pre-specified endpoints," said Petr Neužil, MD, PhD. "With faster PVI and faster total ablation times combined with the already established safety and efficacy of the current HeartLight System, I anticipate that the HeartLight X3 System will be quickly adopted in the clinical setting."

The 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 hour²
HeartLight X3 was able to isolate pulmonary veins in as fast as three minutes
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
Fluoroscopy times with HeartLight X3 were under seven minutes per procedure, substantially lower than with the first generation HeartLight System

"CardioFocus is experiencing tremendous growth; more than 6,500 patients have been treated with our revolutionary HeartLight System and the HeartLight X3 System is poised to make a real impact on the AFib ablation space with its recent CE Mark approval," said Burke T. Barrett, President and Chief Operating Officer at CardioFocus. "We believe coupling the HeartLight System's unique feature set and its safety and effectiveness profile with the straightforward introduction of X3 Rapid mode for accelerating procedures, will result in an unparalleled PVI ablation tool."

The HeartLight X3 System is only approved for use in Europe. The HeartLight X3 System is not available for sale in the U.S.

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 6,500 patients in the United States, Europe and Japan. The HeartLight System 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.

Media Contact:
Helen Winkler
Phone: 949.606.2008
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¹ Dukkipati SR, Cuoco F, Kutinsky I, et.al. Pulmonary Vein Isolation Using the Visually Guided Laser Balloon. JACC Vol. 66, No. 12, September 22 2015:1350-60.
² Neužil P., Schmidt B., Chun J., et.al. Performance of a 3^rd Generation Visually-Guided Laser Balloon Catheter for Pulmonary Vein Isolation: Results of the X3 Study. HRS 2019. Excluding 30 minute wait period with operators out of the learning curve.

SOURCE CardioFocus, Inc.