CardioFocus® Announces Initial Commercial Procedures Following US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation

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Jun 16, 2020, 09:00 ET

MARLBOROUGH, Mass., June 16, 2020 /PRNewswire/ -- CardioFocus, Inc. today announced that the first U.S. patients have been treated commercially with the recently-approved HeartLight^® X3 Endoscopic Ablation System. The revolutionary cardiac ablation technology is designed to treat drug refractory, symptomatic paroxysmal atrial fibrillation (AFib), the most common heart rhythm disorder.

The HeartLight Excalibur Balloon™ used with the new HeartLight® X3 System.

Henry D. Huang, M.D., FACC, FHRS of Rush University Medical Center in Chicago, and David Kenigsberg M.D., FACC, FHRS of Westside Regional Medical Center in Plantation, Florida performed the first procedures using the X3 System.

"We are dedicated to providing our patients the most efficacious and innovative treatment options for AFib, a common but treatable heart condition," Dr. Huang said. "As the initial medical center in the U.S. to offer the HeartLight X3 System, we look forward to being able to provide effective symptom relief for Chicago-area patients safely, confidently and quicker than ever before. We are excited by the results we've seen thus far, which build upon the positive outcomes we experienced in treating more than 100 patients with previous versions of HeartLight."

More than 2.3 million people in the U.S. suffer from AFib, and the numbers are climbing along with the aging population¹. By 2050, AFib is expected to affect 15.9 million people².

"Early on, I recognized the potential of the HeartLight System and after using it to treat more than 40 patients, I have been eager to offer the next-generation, HeartLight X3, to our patients here in South Florida," said Dr. Kenigsberg. "I believe the technology has true game-changing potential in how it facilitates pulmonary vein isolation (PVI)."

The HeartLight X3 System received U.S. Food and Drug Administration (FDA) approval for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF) in May. Approval was based on a comprehensive submission, including outcomes from the study of 60 HeartLight X3 patients over 12 months. All study endpoints were achieved, and the device achieved very rapid PVI, in as few as three minutes for a single pulmonary vein.

"Following the impressive clinical trial results of HeartLight X3, we have been equally encouraged by these initial real-world patient experiences," said Burke T. Barrett, Chief Executive Officer at CardioFocus. "Following the swift FDA approval, we are pleased to have begun a focused commercial rollout of the HeartLight X3 system in the U.S. that will showcase its impressive array of features."

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 HeartLight Endoscopic Ablation System is a revolutionary catheter ablation technology that features an ultra-compliant balloon, which along with direct visualization and titratable laser energy, represents a new standard for AFib ablation. The company has obtained approval and is currently launching its next-generation HeartLight X3 System in Europe and the U.S. This technology offers a unique RAPID mode, which 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. The HeartLight balloon catheter, endoscope, sheath, console and balloon fill media are all manufactured in the US. CardioFocus is headquartered in Marlborough, MA. For more information, visit www.CardioFocus.com.

Media Contact:
Helen Winkler
Phone: 949.606.2008
[email protected]

Federal Law (USA) restricts this device to sale by or on the order of physician. The HeartLight^® X3 Endoscopic Ablation System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. Please consult a physician to determine if the HeartLight X3 is an appropriate treatment option.

¹ Go AS, et al. Prevalence of diagnosed atrial fibrillation in adults. JAMA. 2001;285:2370-2375.
²Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, et al. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation 2006; 114:119–25.

SOURCE CardioFocus, Inc.