CardioFocus Announces Largest Worldwide Study of HeartLight? EAS Acute Clinical Outcomes Presented at Heart Rhythm 2012

MARLBOROUGH, Mass., June 4, 2012 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces new worldwide data with its technology was presented during the scientific sessions at Heart Rhythm 2012, the Heart Rhythm Society's 33rd Annual Scientific Sessions, in Boston, MA last month. The research, representing the first 400 patients treated solely with the HeartLight system, demonstrates an overall 98% acute pulmonary vein (PV) isolation rate, further supporting the high reproducibility of the procedure in clinical practice.  

Lead author Boris Schmidt, MD, of Cardioangiologisches Centrum Bethanien, Frankfurt, Germany, said, "The positive results reported in this multicenter study remain consistent with those of numerous smaller-scale experiences, demonstrating that ablation with HeartLight EAS can be performed with high acute success even by those with limited experience, and helping to validate the continued application of the system in clinical practice. While this presentation focused on acute treatment and initial cases at these worldwide centers, research is ongoing to further evaluate long-term outcomes with a single procedure." 

Titled "Worldwide Experience Using the Endoscopic Ablation System for Ablation of Atrial Fibrillation," the aim of the study was to analyze feasibility and safety of AF ablation using the HeartLight EAS, with the primary endpoint being acute PV isolation. It collected data on 406 patients, drawn both from registries (n=170) and clinical studies (n=236), treated by 33 physicians at 16 medical centers throughout the world. Overall, physicians achieved an acute PV isolation rate of 98%, with 79% of veins being isolated on the very first visually-guided attempt. At 12 months following the single procedure, approximately 60% of patients remained in sinus rhythm.

Average procedure time overall was 180+/-58 min including 107+/-36 min in the left atrium (LA), with average fluoroscopy time of just 29+/-19 min. Notably, procedure time decreased dramatically after about 15 cases, suggesting a short learning curve associated with the technology.

International experiences with the device were also highlighted at a private academic symposium held in conjunction with the meeting.  Electrophysiology thought leaders from the Czech Republic, Germany, the Netherlands and the UK presented on topics regarding the adoption of the system in clinical practice. The physicians also highlighted their experiences refining the new visually-guided laser balloon ablation technique, including continued advances in standardizing variables such as device positioning and energy titration for improved clinical results. Recent published data referenced at the symposium suggest approximately 77% of patients may achieve durable freedom from AF after a single procedure.[1]

Stephen Sagon, President and CEO of CardioFocus, said, "Last year at this meeting, physicians presented data on the first 200 patients treated with the HeartLight EAS. This year's even more comprehensive 400-patient study provides comparable data, further supporting the reproducibility of the procedure and its increasingly widespread utility in the treatment of AF."

The HeartLight EAS is a unique catheter ablation technology that incorporates an endoscope for direct visualization of the inside of the heart and a compliant, dynamically adjustable balloon catheter designed for improved contact with the PV ostium irrespective of the individual patient anatomy. It also utilizes laser energy for more efficient, durable and precise ablation treatment. 

The HeartLight EAS is available in Europe for the treatment of AF, and is currently the focus of a pivotal trial in the U.S. For more information, 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.

[1] B Schmidt et al. Visually Guided Sequential Pulmonary Vein Isolation: Insights into Techniques and Predictors of Acute Success. Journal of Cardiovascular Electrophysiology. Published electronically January 9, 2012.

SOURCE CardioFocus, Inc.