HeartLight™ Endoscopic Ablation System Now Available in the UK

MARLBOROUGH, Mass., Aug. 22, 2011 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight™ Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces that the HeartLight EAS is now available in the United Kingdom. The first AF patients were treated at The Heart Hospital in London on Wednesday, August 17, with additional cases to take place throughout the month.

The procedures were performed by Drs. Edward Rowland and Oliver Segal, consultant cardiologists at The Heart Hospital, and proctored by Dr. Boris Schmidt of Cardioangiologisches Centrum Bethanien, Frankfurt, Germany, an international expert on the HeartLight EAS technology. The Heart Hospital is part of the University College London Hospitals Foundation Trust and anticipates HeartLight EAS could be used in up to half of the nearly 400 AF ablation procedures performed at the hospital every year.

Stephen Sagon, President and CEO of CardioFocus, Inc. said, "With the addition of this important UK center, we are continuing the introduction of HeartLight EAS to leading medical hubs across Europe. We are encouraged by the quick adoption of this technology by leaders in the electrophysiology community and are pleased to bring the possibility of a more durable, reproducible ablation option to an expanding number of AF practitioners and their patients."

HeartLight EAS is a unique catheter ablation technology that incorporates an illuminating endoscope to provide physicians with direct visualization within a beating heart, in real time and without radiation. It also features a compliant, dynamically adjustable balloon catheter for improved contact with the pulmonary vein (PV) ostium and utilizes laser energy for more efficient, precise ablation.

Recent data has demonstrated that approximately 86% of PVs remained persistently isolated after three months following a single procedure with HeartLight EAS(1), with 65% of patients achieving durable freedom from AF.(2)  The technology is available at sites across Europe including Germany, Italy and the Czech Republic and will soon be the subject of a pivotal clinical trial in the United States.

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 received CE Mark in 2009 for the treatment of atrial fibrillation, and is commercially available at leading institutions throughout Europe. The device is investigational in the U.S., with a pivotal study expected to commence in 2011. 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)  S Dukkipati. Persistent Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: Results of a Multicenter PV Remapping Study. Presented at Heart Rhythm 2011.

(2)  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.  

SOURCE CardioFocus, Inc.