Persistent AF Patient Treated with HeartLight™ Endoscopic Ablation System in Live Case at Venice Arrhythmias 2011 -- Scientific Session Also Reveals the Compliant Balloon Catheter Achieves 99% Acute PVI Irrespective of Individual Vein Anatomy --

MARLBOROUGH, Mass., Oct. 12, 2011 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight™ Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces that its HeartLight EAS was used to achieve successful acute PV isolation and restore sinus rhythm in a persistent AF patient during a live case at the Venice Arrhythmias 2011 conference, October 9-12 in Venice, Italy.

Additionally, research presented during the scientific sessions further supports the ability of the compliant balloon system to accommodate varied vein anatomy with a single catheter, achieving 99% acute isolation irrespective of vein size and shape.  

"The live case outcome and clinical findings presented at the conference are exciting, as they've revealed the HeartLight EAS may be suitable for a larger sub-set of patients who are otherwise unable to be treated with a single ablation catheter. We are pleased that research continues to instill confidence in the technology and support its versatile clinical use," said Stephen Sagon, President and CEO of CardioFocus.

In the live case, physicians successfully isolated all four PVs of a patient with persistent AF and restored the patient to normal sinus rhythm. The procedure was performed by leading electrophysiologists Sakis Themistoclakis, MD, of Dell'Angelo Hospital and Andrea Natale, MD, of Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, Texas. The session was chaired by Petr Neuzil, MD, of Na Homolce Hospital, Prague, Czech Republic.

To perform the case, the physicians employed the new HeartLight EAS handle configuration for the first time in Italy. The enhanced handle was designed for single-handed control of both catheter manipulation and the location of energy delivery to improve procedural efficiency.

Dr. Themistoclakis commented, "The HeartLight EAS compliant balloon catheter allows for very good contact with all PVs to deliver a circumferential lesion pattern, which in our experience has translated to more efficient, durable vein isolation. In this particular case, it even enabled conversion to normal sinus rhythm during the ablation of the right superior pulmonary vein. We are optimistic that the system will continue to achieve promising outcomes in patients with both paroxysmal and persistent AF."

The efficacy and precision of endoscopically guided catheter ablation was further supported by a study evaluating the ability of the system to ablate PVs of varying anatomy in 29 unselected paroxysmal AF patients. The research was performed by Boris Schmidt, MD and KR Julian Chun, MD, of Cardioangiologisches Centrum Bethanien, Frankfurt, Germany and presented by Melanie Gunawardene, MD, also of Cardioangiologisches Centrum Bethanien.  They found that visually guided PV isolation was achieved in 72% of veins (83/116) on the very first attempt and that electrical isolation was ultimately confirmed with a diagnostic spiral catheter in 99% of the PVs attempted (115/116) using only a single HeartLight EAS catheter.  

Since its introduction in 2009, the visually-guided HeartLight EAS has been used to treat approximately 400 patients with AF in the United States and in Europe. It incorporates a compliant, dynamically adjustable balloon catheter designed for improved contact with the PV ostium, and utilizes laser energy for more efficient, durable and precise ablation treatment.

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 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.

Company Contact:

Media Contact:

Anjie Roldan

Lisa Cook

Vice President Finance

(646) 536-7012

(508) 658-7237

lcook@theruthgroup.com  

aroldan@cardiofocus.com




SOURCE CardioFocus, Inc.



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