Healthcare Industry News:  Balloon catheter 

Devices Cardiology

 News Release - January 10, 2013

CardioFocus Announces 1,000 HeartLight(R) Cases Performed Worldwide

Company to Convene Expert Symposium in Boston to Discuss Clinical Experiences

MARLBOROUGH, Mass., Jan. 10, 2013 -- (Healthcare Sales & Marketing Network) -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), announces that as of late 2012, more than 1,000 clinical cases have been performed worldwide using the HeartLight technology. The company will be hosting an expert symposium to review the clinical application of HeartLight and key observations made during the first 1,000 cases, which will be held the evening of Thursday, January 17 in Boston, MA.

Prof. Karl-Heinz Kuck, MD of Asklepios Klinik St Georg, Hamburg, Germany, and co-chair of the symposium, said, "Our clinical experience has demonstrated that the HeartLight technology possesses unique capabilities for the treatment of AF. Notably, it allows physicians the ability to directly see the tissue to be ablated, and offers a laser energy source to facilitate the creation of durable lesions irrespective of contact force. My colleagues and I have had the opportunity to evaluate its promising clinical impact, collect and analyze the data, and, now, further refine our technique to give patients the best chance of achieving freedom from AF."

Presentations will focus on topics including techniques for utilizing the endoscopically-guided ablation system, the desired location of pulmonary vein isolation, and the impact of HeartLight laser energy titration on achieving durable results. There will also be a discussion of clinical results obtained using HeartLight in comparison to systems using alternative energy sources. In addition to Prof. Kuck, the event will be co-chaired by Andrea Natale, MD of Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, TX, and Vivek Y. Reddy, MD, of Mt. Sinai University Medical Center, New York, NY. It will begin at 7 p.m. at the InterContinental Hotel Boston.

"This symposium will bring together physicians at leading cardiac centers throughout the world, who have been involved in performing HeartLight procedures and have played a critical role in advancing this technology. We believe that both the presentations and the collaborative discussions will help enhance our understanding of the ideal clinical application and best practices for the use of the system," said Stephen Sagon, President and CEO of CardioFocus.

HeartLight is the first catheter ablation system to incorporate an endoscope, a laser energy source and a compliant Balloon catheter to enable direct visualization of the beating heart during catheter ablation. The system is CE marked and clinically available in Europe and Australia. In the U.S., it is investigational and currently the focus of an ongoing multi-center pivotal trial.

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About CardioFocus, Inc.

CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). Its novel HeartLight® Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.

The HeartLight Endoscopic Ablation System is commercially available at leading institutions throughout Europe and in Australia. The device is investigational in the U.S., and currently the focus of a pivotal trial initiated in 2012. CardioFocus is headquartered in Marlborough, MA, USA. For more information on the company and its technology, please visit

The scientific information discussed in this news release is preliminary and investigative. The CardioFocus HeartLight Endoscopic Ablation System is not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the system. Only FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.

Source: CardioFocus

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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