One-Year Outcomes Data with HeartLight™ Endoscopic Ablation System Presented at European Society of Cardiology Congress 2011

CardioFocus, Inc., developer of the HeartLight™ Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces results from a clinical study representing the first 40 atrial fibrillation patients treated with the HeartLight EAS at Asklepios Klinik St. Georg, in Hamburg, Germany. Outcomes data demonstrating a 99% acute pulmonary vein (PV) isolation rate and a 60% chronic clinical success rate from a single catheter ablation procedure were presented at the European Society of Cardiology (ESC) Congress 2011, in Paris, France. Lead investigator Andreas Metzner, MD, of Asklepios Klinik St. Georg, said, “In these initial catheter ablation procedures using the HeartLight EAS, we were able to achieve a remarkably high PV isolation rate acutely using only a single compliant balloon-equipped catheter to perform the ablation. The one-year outcomes are on par with existing catheter ablation technologies, however, the results are particularly impressive given the single catheter, single procedure approach. These outcomes demonstrate the significant advantage of the system’s direct visualization capabilities and its short learning curve. At the time of this study we had been using the HeartLight EAS for a little more than a year. We expect future outcomes to show that the rate of single procedure clinical success continues to improve with procedural experience.” In the study, 40 patients were treated exclusively with the Heartlight EAS. An even split of male and female patients with an average age of 57 years and a long history of drug-refractory paroxysmal AF (5±4 years) were included. All veins were targeted and a total of 153 out of 155 (99%) PVs were isolated successfully. After a median follow up of 402 days, 24 patients (60%) remained free of any symptomatic or documented AF episode without antiarrhythmic drugs after a single procedure. Complications were low, with no PV stenosis detected three months post ablation based on MRI. Stephen Sagon, President and CEO of CardioFocus, commented, “These are the first reported long-term data from Germany using the HeartLight EAS. We are satisfied that this study provides further evidence that even during the learning curve, physicians become comfortable with our technology and are able to use a single HeartLight EAS catheter to administer consistent, durable ablation treatment in a diverse group of patients from only one clinical procedure.” The novel HeartLight EAS incorporates an illuminating endoscope to provide physicians with direct visualization within a beating heart, in real time and without radiation. It also features a compliant, dynamically adjustable balloon catheter for improved contact with the PV ostium and utilizes laser energy for more efficient, durable and precise ablation. This study was supported by a research grant from CardioFocus and the full manuscript, titled, “One-year clinical outcome after pulmonary vein isolation using the novel endoscopic ablation system in patients with paroxysmal atrial fibrillation,” was published in the July 2011 issue of Heart Rhythm. 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. 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.