MARLBOROUGH, Mass., June 18, 2019 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), announced today that the HeartLight® Endoscopic Ablation System is now offered at more than 100 hospitals worldwide.
The HeartLight System is a revolutionary catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI), the gold standard treatment for AFib. The HeartLight System is an effective and safe treatment option for patients whose heart arrhythmias are insufficiently controlled with medication. More than 6,500 patients have been successfully treated in the U.S., Europe and Japan, with the HeartLight System.
“We have treated dozens of patients with the system, which allows direct visualization of ablation targets during the procedure, and we are encouraged by the outcomes so far,” said Tristram D. Bahnson, MD, a Duke University Health System electrophysiologist and founding director of the Duke Center for Atrial Fibrillation. “For practicing clinical electrophysiologists, it’s important to reduce the need for repeat ablation procedures by using ablation systems that facilitate precise and durable lesion delivery, which is facilitated by the HeartLight system.”
Duke was one of 19 participating sites in the clinical evaluation of the HeartLight System. The trial titled, “Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System,” was a randomized, controlled trial with 353 participants across the United States.[1] Results of this trial led to the device’s U.S. Food and Drug Administration (FDA) approval of the device in 2016. In 2018, the next-generation Excalibur Balloon received FDA approval for use as part of the HeartLight System. In March, the breakthrough HeartLight X3 System received European CE Mark approval.
More than 33 million patients worldwide suffer from AFib,[2], [3] which has been associated with significant symptoms, functional impairment, stroke, cognitive decline, heart failure, and reduced longevity.
“We’ve seen a surge in demand for the HeartLight System and have more than doubled the number of hospitals offering the technology over the last twelve months,” said Omari V. Bouknight, President and Chief Commercial Officer at CardioFocus. “AFib is a widespread, debilitating condition that requires advanced solutions to improve outcomes. By collaborating with leading institutions and physicians in the field, we will make this revolutionary treatment available to a greater number of patients worldwide.”
About CardioFocus, Inc.
CardioFocus is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AFib), the most common heart arrhythmia. The HeartLight Endoscopic Ablation System is a revolutionary catheter ablation technology that along with direct visualization and titratable laser energy, represents a new standard for AFib ablation. In March, the company announced the European CE Mark approval and commercial launch of its third-generation technology, the HeartLight X3 System. This technology builds upon the advanced features of the HeartLight System and offers a unique RAPID mode which leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician resulting in consistently reduced procedure times. CardioFocus is headquartered in Marlborough, MA. For more information, visit www.CardioFocus.com.
The HeartLight X3 System is only approved for use in Europe. The HeartLight X3 System is not available for sale in the U.S.
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[1] Dukkipati, S.R., et. al., J Am Coll Cardiol 2015;66:1350–60
[2] Chugh SS, Havmoeller R, Narayanan K, et al.; Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47.
[3] Chugh SS, Havmoeller R, Narayanan K, et al.; Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47.
SOURCE CardioFocus, Inc.
