CardioFocus Announces HeartLight® EAS Now Available in Australia for the Treatment of Atrial Fibrillation

Monash Medical Centre First in Country to Use New Technology CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces that its technology is now available in Australia for clinical use. Monash Medical Centre in Melbourne is the first cardiology center in the country to offer the innovative catheter ablation treatment for AF, the most common heart arrhythmia in the world, which affects approximately 400,000 Australians.[i] Dr. Emily Kotschet, Electrophysiologist, of Monash Heart, Monash Medical Centre said, “We are excited to bring this treatment option to patients in Australia, where nearly half a million people suffer with atrial fibrillation. Clinical data out of Europe with the HeartLight EAS system have been excellent, demonstrating high acute success and durable efficacy as compared with traditional treatment modalities. The system is straightforward to set up and easy to use. The balloon is compliant, which provides good complete occlusion of each pulmonary vein, and subsequently excellent views of the veins to deliver the laser energy. Our own initial experiences have been promising in treating patients with symptomatic AF. We look forward to continuing to integrate the technology into our practice at Monash Heart.” The HeartLight EAS is the first and only catheter ablation technology to incorporate an endoscope for direct visualization of the inside of the heart, which research is suggesting may contribute to the high rates of acute and durable pulmonary vein isolation achievable with the system. It also features a compliant, dynamically adjustable balloon catheter designed for improved contact with the area surrounding the pulmonary veins, irrespective of the individual patient anatomy, and utilizes laser energy for more efficient and precise ablation treatment. Stephen Sagon, President and CEO of CardioFocus, said, “Entering into Australia represents another milestone for CardioFocus and speaks to the value that clinicians throughout the world are experiencing with our technology. We are pleased that such a renowned cardiology care center is leading the way in introducing the HeartLight EAS, and we plan to respond to demand for the technology at prominent centers across the country in the coming months.” In addition to Australia, the system is available throughout Europe and is currently the focus of a pivotal, premarket approval clinical trial in the U.S. For more information on the HeartLight EAS technology and its use in the treatment of AF, 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 and now 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, USA. For more information on the company and its technology, please visit www.CardioFocus.com. 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 in the U.S. 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. [i] Atrial Fibrillation Association – Australia