First Clinical Results in the Netherlands with CardioFocus’ HeartLight® System Presented at Netherlands Society of Cardiology Congress

Data Show High Acute Success and Freedom from Atrial Fibrillation at Six Months Follow-up CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), announces new data from the first patients treated with the HeartLight system in the Netherlands, showing high acute pulmonary vein isolation rates of 98% and up to 78% of patients remaining free from AF after six months of follow-up. The study was presented at the Netherlands Society of Cardiology (NVVC) Congress, October 4-5. Investigator Arif Elvan, MD, of Isala Klinieken in Zwolle, said, “Since adopting the HeartLight technology at our center, we have achieved consistently high acute patient outcomes, with very promising durable results to date in treating both paroxysmal and persistent AF. We have found that the novel design of the system, which allows physicians to see inside the beating heart throughout the procedure, contributes to the ease of use and overall reproducibility of the ablation procedure. These benefits have been validated through the positive patient results presented at the Congress.” In the prospective study, 40 patients (33 with paroxysmal AF, 7 with persistent AF) with mean AF duration of 7.7 years underwent a single pulmonary vein isolation procedure using the HeartLight system. Researchers achieved acute isolation in 98% of veins (157/160), with 73% of patients (24/33) remaining free from AF after at least three months follow-up and 78% (14/18) free from AF after at least six months follow-up. Stephen Sagon, President and CEO of CardioFocus, said, “The introduction of our technology at Isala Klinieken late last year was a milestone for the company as we continue to expand throughout Europe and Australia. We are particularly encouraged by the consistent, positive outcomes achieved by Dr. Elvan and his team in their very first patient series.” 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. To see more EP-related news, please visit: https://eplabdigest.com/articles/EP-News-6