MARLBOROUGH, Mass., Dec. 15, 2020 /PRNewswire/ -- CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), announced today that more than 10,000 patients worldwide have been treated with the HeartLight® Endoscopic Ablation System.
The HeartLight System is a revolutionary catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI), the gold standard treatment for AFib. HeartLight is a treatment option for some patients whose AFib is insufficiently controlled with medication1.
Extensive clinical studies of the HeartLight System and the new HeartLight X3 System demonstrated that AFib patients can be treated quickly and with excellent procedure time predictability.2 In May of this year, the U.S. Food and Drug Administration (FDA) approved the next-generation HeartLight X3 System. This third generation HeartLight X3 System offers a unique RAPID mode, which includes precise motor control that enables uninterrupted, high-speed, circumferential lesion creation under direct visual control of the physician resulting in consistently reduced procedure times.3
"As an early adopter of the HeartLight System, I have seen firsthand the benefits this transformational technology provides AFib patients," said Henry D. Huang, M.D., a cardiac electrophysiologist at Rush University Medical Center in Chicago. "The speed, control, predictability and durability of HeartLight X3 are unparalleled and allow us to customize the treatment based on the unique needs of each patient."
More than 33 million patients worldwide suffer from AFib,4 which has been associated with significant symptoms, functional impairment, stroke, cognitive decline, heart failure, and reduced longevity.
"We are committed to providing our AFib patients with the latest advancements in cardiac treatments, including devices like the HeartLight X3 System," said David N. Kenigsberg, MD, clinical cardiac electrophysiologist and medical director of the electrophysiology laboratory at Westside Regional Medical Center in Plantation, Fla. "I am honored to be among the group of electrophysiologists helping to achieve the 10,000 patient HeartLight milestone and furthering the reach of this revolutionary technology."
"CardioFocus values our partners and the leaders in the electrophysiology community who have made this noteworthy milestone a reality. Their collaboration and unwavering commitment to exceptional patient care have expedited the adoption of this technology at a remarkable pace," said Burke T. Barrett, Chief Executive Officer & President at CardioFocus. "With more than 10,000 patients treated worldwide, we believe this is only the beginning, as CardioFocus is positioned to become a dominant force in the rapidly growing AFib ablation market with our proven HeartLight X3 System."
CardioFocus is celebrating the treatment of the 10,000th patient by thanking the countless researchers, scientists, clinicians, suppliers, vendors, partners, investors and employees (both past and present) that helped develop the HeartLight System. For more information on our 10,000 patient celebration, please visit www.cardiofocus.com/10K.
About the HeartLight System The HeartLight X3 System is a next-generation AFib ablation technology, building upon the advanced features of the HeartLight Endoscopic Ablation System. The system performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib. Using direct tissue visualization, titratable laser energy and compliant balloon technology, the HeartLight X3 System offers a unique RAPID mode. RAPID mode leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician, resulting in significantly reduced procedure times. During the pivotal confirmatory study of 60 patients, the HeartLight X3 System achieved very rapid PVI, in as few as three minutes for a single pulmonary vein.
About CardioFocus, Inc. Founded in 1990 and headquartered in Marlborough, MA, 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 balloon catheter, endoscope, sheath, console and balloon fill media are all manufactured in the USA. For more information, visit www.CardioFocus.com.
1 In the United States, the HeartLight System is indicated to treat drug refractory, symptomatic, paroxysmal atrial fibrillation (AFib).
2 X3 total procedure time was statistically significantly shorter than the original HeartLight and irrigated radiofrequency ablation (RF) ablation based on a comparison to the original HeartLight pivotal study (historical control).
3 Predictability is determined by the standard deviation of the procedure time.
4 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.