Press Release
CardioFocus HeartLight™ Endoscopic Ablation System to be Highlighted in Scientific Session and Live Case Program at Venice Arrhythmias 2011
10/03/2011
CardioFocus, Inc., developer of the HeartLight™ Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces that its technology will be highlighted in both an abstract presentation and a “live case” session, in which a patient with persistent AF will be treated by leading electrophysiologists, at the upcoming Venice Arrhythmias 2011 conference, October 9-12 in Venice, Italy.
“Venice Arrhythmias is a renowned conference for cardiac electrophysiology specialists, and we are excited that our technology has been selected to have such a prominent role in this year’s scientific sessions,” said Stephen Sagon, President and CEO of CardioFocus.
On Sunday, October 9, Melanie Gunawardene, MD, of Cardioangiologisches Centrum Bethanien, Frankfurt, Germany will present an abstract entitled, “Does pulmonary vein anatomy play a role for acute success of pulmonary vein isolation using the endoscopic ablation system?” The study evaluates the ability of a single HeartLight EAS catheter to ablate pulmonary veins (PVs) of varying anatomical shapes in 29 unselected paroxysmal AF patients.
On Tuesday, October 11, in a live case presentation, the HeartLight EAS will be used to perform PV isolation on a patient with persistent AF. “A case of laser balloon AF ablation” will be conducted at Dell’Angelo Hospital, Venice-Mestre, Italy, one of the first centers in the world to treat patients with this novel technological approach.
The case will be performed by 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 live case session will be chaired by Petr Neuzil, MD, of Na Homolce Hospital, Prague, Czech Republic, and will be presented in the Carnelutti Room at 1 p.m. local time.
Dr. Themistoclakis commented, “My colleagues and I have seen very positive clinical outcomes with the HeartLight device in treating paroxysmal patients, with nearly all veins remaining isolated years after the initial procedure. Because of these experiences, we are encouraged to begin treating patients with persistent forms of AF using this particularly effective technology.”
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, please visit the CardioFocus Venice Arrhythmias booth #43 or go to 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.



