MARLBOROUGH, Mass. - CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), convened cardiology thought leaders to discuss clinical experiences with its technology and identify areas for continued research during a sponsored symposium at the German Society of Cardiology Annual Meeting in Mannheim, Germany, April 11-14. Presenters highlighted the versatility and durability of endoscopic laser catheter ablation, and addressed topics related to the unique energy delivery mechanism and its applicability in a range of patient anatomies.
The program, "Two years of laser ablation with the endoscope: First results and outlook," was chaired by Prof. Thorsten Lewalter, MD, of Isar Heart Center Munich, Germany, and Boris Schmidt, MD, of Cardioangiologisches Centrum Bethanien, Frankfurt, Germany. It featured presentations ranging from single center experiences to a worldwide, multicenter 400 patient experience with the HeartLight EAS, the first catheter ablation system to feature an endoscope for direct visualization of the beating heart. The system also incorporates a compliant, dynamically adjustable balloon catheter for improved contact with the pulmonary vein (PV) ostium and unique laser energy source for more efficient, precise ablation.
"The symposium featured notable acute and long-term data on the ease of use and PV isolation enabled by the HeartLight EAS, further supporting the value of integrating the system into clinical practice," said Dr. Schmidt. "With over two years of experience with the technology in Germany and documented successful patient outcomes, the system has become an established AF treatment option at many centers. We look forward to continuing to delve deeper into the applicability of the system and the nuances of laser energy delivery."
In one presentation, Erik Wissner, MD, of Asklepios Klinik St. Georg, Hamburg, Germany, further explored the impact of variables including patient selection and energy titration on acute PV isolation with the HeartLight EAS. His research demonstrated a high rate of acute PV isolation (192/195), irrespective of individual patient anatomy, with no correlation between isolation gap location and PV anatomy. Additionally, he noted first-of-its kind data suggest the system can achieve up to 90% isolation (36/40) after a single circumferential lesion set when using a higher energy level (8.5/10W), while maintaining a similar safety profile to lower energy ablation.
"Our clinical experiences suggest the HeartLight EAS is a highly adaptable system that can be widely used to treat patients with paroxysmal AF, at varied energy levels and independent of individual anatomy, enabling greater intra-operative versatility," said Dr. Wissner. "Further, we've achieved these results while maintaining the low complication rate and high single procedure efficacy that have come to be associated with HeartLight EAS ablation. We will continue to explore the potential of the technology to deliver complete PV isolation with a single lesion set, with energy levels that remain lower than that of alternative systems."
For more information on 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.
Web Site: www.cardiofocus.com