CardioFocus HeartLight® Demonstrates High-Dose Visually Guided Laser Ablation Superior to Low-Dose Ablation in New Study

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CardioFocus HeartLight® Demonstrates High-Dose Visually Guided Laser Ablation Superior to Low-Dose Ablation in New Study

PR Newswire MARLBOROUGH, Massachusetts, Nov. 19, 2012

- Data Published in EP-Europace shows high-dose ablation results in acute PVI rate of 89% and long-term success rate of 83% off antiarrhythmic drugs after a single procedure

MARLBOROUGH, Massachusetts,Nov. 19, 2012/PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), announces new data demonstrating the superior benefits of high-dose laser ablation compared to low-dose treatment. Using the HeartLight System, investigators in Frankfurt, Germany were able to achieve an acute PVI rate of 89% after an initial visually guided ablation circle and reported a long-term clinical success rate of 83% off antiarrhythmic drugs after a single procedure.

The data, representing the first examination of varying laser ablation energy on both the acute and long-term outcomes in patients with drug refractory AF, is published in theNovember 2012online issue ofEP-Europace— TheEuropean Journal ofPacing,Arrhythmias andCardiacElectrophysiology of the European Heart Rhythm Association of the European Society of Cardiology.

Investigator Boris Schmidt, MD, of Cardioangiologisches Centrum Bethanien,Frankfurt, Germany, said, "Laser ablation with the HeartLight System has demonstrated proof of concept in many feasibility studies over the last few years and has become routine in my practice. In this clinical experience, we aimed to understand the optimal energy needed to achieve chronically transmural lesions and provide guidance on different energy dosing strategies. We are most pleased to find that high-dose ablation demonstrates such significant clinical benefits. In particular, most patients in the HD group were found to be free of AF symptoms almost 11 months after the single ablation procedure."

The study titled "Energy titration strategies with the endoscopic ablation system: lessons from the high-dose vs. low-dose laser ablation study," involved 60 symptom atic, drug refractory AF patients between the ages of 18-70 who had never before had PVI attempted to control their AF symptoms. Patients were prospectively assigned to two groups, high-dose and low-dose, for PVI with the HeartLight System. In the HD group ablation energy was titrated at >8.5 to 12W and in the LD group it was titrated at 5.5 < 8.5W. The number of laser applications and total energy deployed was collected for each individual pulmonary vein.

The findings demonstrate that acute PVI was achieved after a single visually guided circular lesion set in 89% and 69% of patients in the HD and LD groups, respectively. During a mean follow-up of 311 days, the AF recurrence rate was only 17% in the HD group while 40% in the LD group. In addition, it was found that HD ablation significantly reduced procedure times, by reducing the number of ablation lesions needed and lowering the need for gap mapping (128+17 vs. 154+38 min; P = 0.001).

Stephen Sagon, President and CEO of CardioFocus, said, "This publication reveals the benefits of high-dose laser ablation and continues to validate the HeartLight technology. It also represents the creative fine tuning of our unique and innovative ablation technique by key thought leaders in the field. We hope this clinical experience will provide a guide to current and new HeartLight adopters to inform dosing strategies and optimize results for patients."

HeartLight is the first cardiac ablation system to feature an endoscope for intra-procedural visualization of the beating heart, in combination with a laser energy source to achieve more precise and durable ablation results. 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 visithttp://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 and in Australia. 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, US A. For more information on the company and its technology, please visithttp://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.

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