Heart Rhythm Study Shows CardioFocus HeartLight EAS Provides Durable Pulmonary Vein Isolation in Treatment of Atrial Fibrillation Unique Remapping Study Finds 86% of PVs Remained Electrically Isolated and Notes Physician Learning Curve of Only 10 Cases
MARLBOROUGH, Mass., June 13, 2012 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces that a unique study in the journal Heart Rhythm demonstrates high acute success (98%) and durable pulmonary vein (PV) isolation rates achievable with a single, visually-guided HeartLight EAS ablation procedure. To determine durability, the study involved a subsequent diagnostic remapping procedure that found 86% of PVs remained electrically isolated after three months. The multicenter study, authored by Srinivas R. Dukkipati, MD, Mount Sinai School of Medicine, New York, is published in the June 2012 issue.
"The goal of catheter ablation for paroxysmal AF is durable PV isolation, and this study demonstrates that the unique compliant, variable-diameter balloon catheter and laser energy source of the HeartLight EAS enables the placement of circumferential and continguous lesions for high rates of acute and persistent PV isolation," said Dr. Dukkipati. "Through the insights gleaned in the remapping procedures we have been able to hone our techniques for energy application, catheter positioning and other procedural elements and are continuing to obtain impressive clinical outcomes with the system."
The study, "The Durability of Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon Catheter: Multicenter Results of Pulmonary Vein Remapping Studies," looked at the first 56 patients treated with HeartLight EAS by 10 primary operators at three European sites, resulting in an acute PV isolation rate of 98% (202/206). At approximately three months follow-up (105 +/= 44 days), 52 patients returned for a remapping procedure to reconfirm electrical isolation, in which researchers found 86% (162/189) of PVs remained isolated. During the remapping, if a PV had reconnected physicians performed repeat ablation. At an average follow-up of one year (12.0 +/= 1.8 months post remapping), 71% of patients remained free from AF and off anti-arrhythmic drugs.
Notably, after performing only 10 cases, physicians began to see improved outcomes. Data from the remapping shows physicians who performed fewer than 10 cases achieved a durable PV isolation rate of 73% (38/52), while physicians who had performed 10 or more cases achieved a rate of 89% (127/142).
"This data continues to contribute to the growing body of research supporting HeartLight EAS as an effective treatment option for AF with a remarkably quick learning curve," said Stephen Sagon, President and CEO of CardioFocus. "As adoption continues throughout Europe and momentum builds in our U.S. pivotal trial, we are excited that such positive clinical experiences are being documented by leading electrophysiologists and shared in prominent forums such as the journal Heart Rhythm."
HeartLight EAS incorporates an endoscope for direct visualization of a beating heart and a compliant, dynamically adjustable balloon catheter designed for improved contact with the PV ostium irrespective of individual patient anatomy. The system also utilizes laser energy for more efficient, durable and precise ablation treatment. CardioFocus will be featuring the technology this week at Cardiostim 2012, the 18th World Congress in Cardiac Electrophysiology & Cardiac Techniques, in Nice, France, at its booth #F23.
The Heart Rhythm study findings were first previewed at Heart Rhythm 2011, the Heart Rhythm Society's 32nd Annual Scientific Sessions. For more information about the HeartLight EAS, 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.
SOURCE CardioFocus, Inc.