CardioFocus Announces HeartLight® Now Available in Spain for the Treatment for Atrial Fibrillation

Hospital Universitari i Politecnic La Fe in Valencia is First in Country to Use New Technology

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Jan 09, 2014, 08:05 ET

MARLBOROUGH, Mass., Jan. 9, 2014 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces that its technology is now available in Spain for clinical use. Physicians at Hospital Universitari i Politecnic La Fe in Valencia were the first in the country to offer the innovative catheter ablation technology for the treatment of AF, the most common heart rhythm disorder in the world.

Dr. Joaquin Osca, a cardiologist who led the first cases in Valencia, said, "We have had an excellent clinical experience with the HeartLight technology and look forward to offering this treatment option to more patients. One of the special features of the HeartLight is the fast learning curve compared to other ablation devices, as well as the laser energy, which is very effortless to use when isolating the pulmonary vein."

The HeartLight EAS is the first catheter ablation system to incorporate an endoscope for direct visualization of the pulmonary vein in a beating heart, in real time and without radiation. It also includes a compliant balloon catheter designed for improved contact with the area surrounding the pulmonary veins, irrespective of individual patient anatomy, and a laser energy source designed to deliver more efficient, precise, and durable ablation treatment.

Stephen Sagon, President of CardioFocus, said, "Within the last year, our technology has been rapidly adopted by physicians across Europe, which speaks for the high value clinicians place on a technology that provides them with direct visualization and delivers a precise ablation. We look forward to building on this momentum and the continuing adoption of HeartLight."

In addition to Spain, the HeartLight system is commercially available in select countries within the European Union and in Australia. The HeartLight EAS is also the focus of a pivotal clinical trial in the U.S. now in its post-treatment follow-up phase

To learn about the Company and its HeartLight technology, please visit www.CardioFocus.com.

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 due to conclude in 2014. CardioFocus is headquartered in Marlborough, MA, USA. For more information on the company and its technology, please visit www.CardioFocus.com.

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.