Results from these three studies will provide additional clinical evidence on the performance of the HeartLight System in the AF population, helping to support its usage as a gold standard catheter ablation therapy.
These studies follow positive data presented last month, at the Heart Rhythm Society's (HRS) 38th Annual Scientific Sessions in Chicago. Outcomes data on the HeartLight system were presented by Dr. Pieter Koopman of the Heart Center Hasselt in Hasselt, Belgium, Dr. Scott Gall of the Lancashire Cardiac Centre in the United Kingdom, Dr. Boris Schmidt, from CCB, Dr. Aditi Naniwadekar of the Helmsley Center for Cardiac Electrophysiology at Mt. Sinai Hospital, New York, and Dr. Rosa M. Figueras i Ventura of the Hospital Clinic of Barcelona.
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"The data continue to reinforce the chronic efficacy of laser balloon ablation with the HeartLight System in our most recent single center comparative analysis showing freedom from AF at one year of 93 percent," said Dr. Pieter Koopman.
"We are greatly encouraged by all the positive data collected to date on the HeartLight System and look forward to the results of these new exciting studies enrolling up to 1,000 AF patients," said Paul A. LaViolette, Executive Chairman of CardioFocus. "Our goal is to be a leader in the field of pulmonary vein isolation, which includes supporting the initiation of clinical studies that provide further evidence of the HeartLight System's impressive safety and efficacy profile and make this technology more widely accessible to the more than 9 million patients, in the U.S. and Europe, who are suffering from AF."
About the HeartLight Endoscopic Ablation System
The HeartLight Endoscopic Ablation System is a revolutionary catheter ablation technology designed for the treatment of atrial fibrillation (AF), the most common heart arrhythmia. The HeartLight System's direct visualization, titratable laser energy, and universal balloon design make it a new standard for pulmonary vein isolation (PVI) procedures. The device received CE Mark in 2009 and U.S. FDA approval in April 2016. In the U.S., the HeartLight System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal AF. More than 2.3 million people in the United States suffer from AF, and the numbers are climbing along with the growing older population.2 More than 4,500 patients with AF have been successfully treated with the system
About CardioFocus, Inc.
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 HeartLight® Endoscopic Ablation System is commercially available at leading institutions throughout the United States and Europe. CardioFocus is headquartered in Marlborough, Mass.
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