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CardioFocus® Completes Successful Controlled U.S. Commercial Launch of the HeartLight® System

Company to Accelerate Market Expansion After Tenth U.S. Site Initiation

MARLBOROUGH, MA - November 29, 2017 - CardioFocus, Inc. today announced the successful completion of its controlled U.S. commercial launch of the HeartLight® Endoscopic Ablation System for the treatment of paroxysmal atrial fibrillation (AF). Ten leading cardiac centers across the country have initiated HeartLight programs.

The HeartLight System is a visually guided laser balloon technology for controlled and consistent pulmonary vein isolation (PVI) treatment of AF. Its direct visualization, titratable laser energy, and universal balloon design make it a new standard for PVI procedures. It provides an effective and safe treatment option for patients whose heart arrhythmias are insufficiently controlled with medication. More than 2.3 million people in the U.S. suffer from AF, and the numbers are climbing along with the aging population.1

"We strategically partnered with select U.S. medical centers to execute the successful controlled launch of the HeartLight System. Initiating a program at a tenth U.S. site is a notable milestone and underscores the company's commitment to advancing the treatment options offered to a large and underserved AF market," said Paul LaViolette, CardioFocus Executive Chairman. "We look forward to continued momentum as we significantly accelerate commercial expansion of the HeartLight System to the substantial number of leading hospitals that have expressed interest in initiating programs. We are also looking forward to introducing our next-generation technology, the HeartLight Excalibur Balloon™ to the U.S. market next year."

To rapidly advance U.S. product awareness, training and customer adoption of the HeartLight System, CardioFocus has built a national sales force consisting of a team with more than 150 years combined experience in the fields of cardiology and electrophysiology. Through its direct efforts, the team has established a robust pipeline of more than 100 additional U.S. cardiology centers that have noted a strong interest in initiating HeartLight programs.

Physician experience with the HeartLight System has been positive, with users affirming their excitement about the technology's unique features.

"Several unique characteristics make the HeartLight System a technology that is transformational in the way it enables us to treat AF," said Sanjay Deshpande, MD, Medical Director, Cardiac Electrophysiology, Columbia St. Mary's, Milwaukee, Wis. "For the first time, we are able to see within the heart and visually direct the application of therapeutic laser energy. The system also allows for procedural flexibility through a highly compliant balloon that easily accommodates diverse anatomies."

Michael Mangrum, MD, Associate Professor, University of Virginia agreed, adding that early patient outcomes in the commercial setting have also been promising.

"In our clinic, we are seeing outcomes that make us confident to offer the HeartLight System as an ablative therapy for patients with paroxysmal AF in whom medication alone is insufficient," said Dr. Mangrum. "There is a tremendous opportunity for this technology to change the way we are managing the treatment of AF patients."

About CardioFocus, Inc.
Headquartered in Marlborough, Mass., 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 first product, the HeartLight® Endoscopic Ablation System is a revolutionary catheter ablation technology designed for the treatment of AF, the most common heart arrhythmia. The device received CE Mark in 2009, U.S. FDA approval in April 2016 and Japan PMDA approval in July 2017. More than 4,500 patients with AF have been successfully treated with the system. For more information, visit www.cardiofocus.com.

1 Go AS, et al. Prevalence of diagnosed atrial fibrillation in adults. JAMA. 2001;285:2370-2375

SOURCE CardioFocus, Inc.
Related Links
http://www.cardiofocus.com