CardioFocus HeartLight® Endoscopic Ablation System Now Available in the Netherlands

MARLBOROUGH, Mass., March 26, 2012 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces its technology is now available in the Netherlands. Physicians at Isala Klinieken in Zwolle were the first in the country to incorporate visually guided ablation into their regular therapeutic practice and have successfully treated several patients.

Arif Elvan, MD, who led the first cases, said, "The HeartLight EAS technology presents a unique approach to AF ablation, offering direct, real-time visualization inside a beating heart , as well as remarkable ease of use for physician operators. Our clinical experience to date is in line with research showing the high acute efficacy of the system, and we are excited to bring this innovative treatment option to patients in the Netherlands."

The HeartLight EAS is a unique catheter ablation technology that incorporates an endoscope for direct visualization and a compliant, dynamically adjustable balloon catheter designed for improved contact with the pulmonary vein (PV) ostium irrespective of the individual patient anatomy. It also utilizes laser energy for more efficient, durable and precise ablation treatment. Research has demonstrated an acute PV isolation rate of 99%, with approximately 77% of patients achieving durable freedom from AF after a single procedure.[1],[2]

"Isala Klinieken is one of the premier cardiology centers in the country and we are pleased they have chosen to incorporate the HeartLight EAS technology into their AF treatment offering," said Stephen Sagon, President and CEO of CardioFocus. "Within the last year, our technology has entered into several new countries and become established at numerous European sites. We look forward to building on this momentum and continuing adoption of HeartLight EAS throughout Europe."

HeartLight EAS is currently available in the Czech Republic, Germany, Italy, the UK and now the Netherlands. For more information about the HeartLight EAS or CardioFocus, 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. 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 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.

[1] VY Reddy et al. Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: The First 200-Patient Multicenter Clinical Experience. Presented at Heart Rhythm 2011. 

[2] B Schmidt et al. Visually Guided Sequential Pulmonary Vein Isolation: Insights into Techniques and Predictors of Acute Success. Journal of Cardiovascular Electrophysiology. Published electronically January 9, 2012.

SOURCE CardioFocus, Inc.