CardioFocus Receives Unique Classification Code (OPS) in Germany for the Treatment of Atrial Fibrillation Using the HeartLight® Ablation System

CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), announced that the German Institute of Medical Documentation and Information (DMDI) has issued a unique classification code (OPS), code 8-835.e, for treatment of the pulmonary veins by laser ablation guided by endovascular endoscopy for patients with atrial fibrillation (AF). Use of the new code allows the DMDI to track the number of patients being treated with this particular technique and provides the initial step to receiving a specific diagnosis-related group (DRG) code for the procedure. As a result of the issuance, hospitals using the CardioFocus HeartLight Endoscopic Ablation System can now apply for supplementary payments from insurers using the "Neue Untersuchungs- und Behandlungsmethoden (NUB).” The NUB system encourages the use of new technologies, like the Heartlight Endoscopic Ablation System, that benefit patients, but do not yet fit adequately into the present reimbursement coding system. Prof. Thorsten Lewalter, MD, of Isar Heart Center Munich, said: “We have been using the HeartLight endoscopic ablation system for nearly two years and are very impressed with both the results of our own experience and of the published clinical data, which continues to support the idea that this approach can be more effective and lead to fewer repeat procedures for patients. This is a benefit to both the patient and the healthcare system providing reimbursement for the procedure. However, at present the technique could be better reimbursed and we think the OPS code and our NUB application are a step in the right direction to rectify this situation.” At this year’s European Society of Cardiology (ESC) Congress in Munich, an abstract authored by Boris Schmidt, MD, and other researchers from the Cardioangiologisches Centrum Bethanien jn Frankfurt, Germany, found that patients treated with the HeartLight Endoscopic Ablation System have a significantly lower rate of arrhythmia recurrence in comparison to procedures employing the cryothermal balloon catheter. The reduction in the number of repeat procedures provides a benefit to both patients, as well as insurance companies, as it decreases costs. HeartLight is the first cardiac ablation system to feature an endoscope for intraprocedural visualization of the beating heart, in combination with a laser energy source to achieve more precise and durable ablation results. For more information on CardioFocus or the HeartLight technology, 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 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, 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.