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CardioFocus® Announces Initiation of Three Major Studies Featuring the HeartLight® System for the Treatment of Atrial Fibrillation

Studies follow recently presented positive chronic results

MARLBOROUGH, MA - June 29, 2017 - CardioFocus, Inc., a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF), today announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical studies currently underway. Collectively, up to 1,000 AF patients will be enrolled in these studies.

  • The first study, titled, "CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation (CF²)," is a prospective, multi-center, randomized study comparing the acute procedure and safety outcomes as well as long-term clinical outcomes of two groups of patients. One group is being treated with the HeartLight System and the other with a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) ablation catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of paroxysmal AF. The study will recruit up to 350 patients at approximately 10 centers throughout Europe. Dr. Andreas Metzner from Asklepios Klinik St. Georg in Hamburg, Germany is leading the study.
  • A second randomized study, led by the Cardiovascular Center Bethanien (CCB) in Frankfurt am Main, Germany, will enroll a total of 400 patients in Europe. 100 patients with paroxysmal AF will be treated with the HeartLight System and 100 paroxysmal AF patients will be treated with the Cryoballoon. Additionally, 100 persistent AF patients will be treated with the HeartLight System and 100 persistent AF patients will be treated with the Cryoballoon. Comparisons across these groups will be analyzed. Drs. Boris Schmidt and Julian Chun, from CCB are the principal investigators for this study. Both previously authored a paper comparing the performance of the HeartLight System to ablation with the Cryoballoon in the paroxysmal AF population. That study showed a 73 percent success rate (freedom from AF) at 12 months with the HeartLight System as compared with 63 percent with the Cryoballoon.
  • The third study, titled, "The Post-Approval Study (PAS) of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation," is evaluating the clinical outcomes of a cohort of patients treated during commercial use of the HeartLight System to confirm results of the successful U.S. clinical pivotal study and study additional research questions. The study will include up to 250 enrolled patients and up to 25 sites in the U.S.

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.

"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 million1 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. For more information, visit www.cardiofocus.com.

1 "What is Atrial Fibrillation?" World Health Federation. http://www.world-heart-federation.org/what-we-do/awareness/atrial-fibrillation/what-is-atrial-fibrillation/. (Accessed May 23, 2017).
2 Go AS, et al. Prevalence of diagnosed atrial fibrillation in adults. JAMA. 2001;285:2370-2375.