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CardioFocus to Exhibit and Present Data Supporting HeartLight X3 System at Heart Rhythm 2021

·5 min read

MARLBOROUGH, Mass., July 19, 2021 /PRNewswire/ -- CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced its participation and presence at the Heart Rhythm 2021 conference, taking place in person at the Boston Convention & Exhibition Center and virtually, July 28-31, 2021.

CardioFocus, Inc. Logo
CardioFocus, Inc. Logo

CardioFocus will place it's HeartLight X3 System's atrial fibrillation (AFib) treatment front and center at the conference – displaying the device's precise motor control RAPID system, enabling uninterrupted, high-speed, circumferential lesion creation under the direct control of physicians, allowing for safe and effective pulmonary vein isolation (PVI).

Dr. Henry D. Huang, Associate Professor of Medicine and Director of Complex Ablation Program at Rush University Medical Center; Dr. David Kenigsberg, Medical Director and Co-Founder at Florida Heart Rhythm Specialists and Fort Lauderdale Heart and Rhythm Surgical Center and Medical Director in Cardiac Electrophysiology at Westside Regional Medical Center; and Dr. Moritoshi Funasako, Interventional Cardiologist at Na Homolka Hospital in Czech Republic, will present data supporting the use of the U.S. Food & Drug Administration approved HeartLight X3 System as outlined in the following four abstracts:

  • #5763 – A Prospective Multicenter U.S. Comparison Of Radiofrequency, Cryoballoon, And Laser Balloon Modalities For Pulmonary Vein Isolation Ablation In Patients With Atrial Fibrillation – Rush & WSMC (Chronic Data) – Wednesday, July 28, 1:40-1:50pm ET – Board no. B-PO01-045

  • #6702 – Prospective Randomized Multicenter Comparison Of Third Generation Cryoballoon And Laser Balloon Catheters For Pulmonary Vein Isolation In Patients With Paroxysmal Atrial Fibrillation – Rush & WSMC (Acute Data) – Thursday, July 29, 10:10-10:20am ET – Board no. B-PO02-078

  • #6122 – A Prospective, Multicenter Comparison Of Radiofrequency, Cryoballoon, And Laser Balloon Ablation For Pulmonary Vein Isolation In Patients With Atrial Fibrillation: Acute Procedural Findings – Rush & WSMC – Friday, July 30, 10:10-10:20am ET – Board no. B-PO04-100

  • #5914 – Safety And Efficacy Of Continuous Rapid Mode With The 3rd Generation Laser Balloon Ablation System – Na Homolka – 110 X3 Patients (Acute Data) – Friday, July 30, 12:30-12:40pm ET – Board no. B-PO05-091

Abstracts will be available Tuesday, July 27 at 5:00pm ET. Abstracts and presentations can be accessed, once live, at: https://heartrhythm.com/

Rhythm Theatre Presentation
Additionally, Dr. Kenigsberg will chair a Rhythm Theater presentation titled, "Visualize Rapid PVI: Fast, Flexible and Contiguous PVI with the HeartLight X3 Endoscopic Ablation System." Presentations will be made by Dr. Huang, Dr. Shiro Nakahara, Associate Professor of Medicine at Dokkyo Medical University Saitama Medical Center in Japan, Dr. Atul Bhatia, Chief Cardiologist at Aurora St. Luke's Medical Center, and Dr. Pieter Koopman, Cardiac Electrophysiologist at Jessa Ziekenhuis in Belgium, on July 29, 2021, from 11:30a.m.-12:30p.m. ET, in Exhibit Hall, Rhythm Theater #2.

CardioFocus will be anchored at Heart Rhythm 2021 in Booth 310, boasting 900 square feet of exhibition space with four monitors and two interactives for attendees. The Direct Visualization station will highlight a feature no other company in electrophysiology has available for physicians – a direct look into the heart and the pulmonary veins. The ability to see the treatment area and stable contact throughout the treatment process. The Mentice Simulator allows hands-on procedural training, giving attendees the opportunity to isolate pulmonary veins with the laser balloon in a mock EP lab setting. The Ablation Simulation/Procedural Suite will give attendees the opportunity to use laser energy in RAPID mode ablation – a hands-on and large-scale approach to explaining how HeartLight X3 ablates in the heart.

For addition information and to register for Heart Rhythm 2021, please visit: https://www.hrsonline.org/heart-rhythm-2021.

About the HeartLight X3 System
The HeartLight X3 System is a revolutionary catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI), the gold standard treatment for atrial fibrillation (AFib). Using direct tissue visualization, titratable laser energy and compliant balloon technology, the HeartLight X3 System is a truly differentiated PVI solution. HeartLight is a treatment option for some patients whose AFib is insufficiently controlled with medication1. More than 33 million patients worldwide suffer from AFib2, which has been associated with significant symptoms, functional impairment, stroke, cognitive decline, heart failure, and reduced longevity. HeartLight X3 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. Clinical studies of the HeartLight X3 System demonstrated that AFib patients can be treated quickly resulting in consistently reduced procedure times with excellent procedure time predictability.3,4

About CardioFocus, Inc.
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 X3 catheter, endoscope, sheath, console and balloon fill media are all manufactured in the USA. For more information, visit http://www.CardioFocus.com.

Media Relations
Sean Leous

1 In the United States, the HeartLight System is indicated to treat drug refractory, symptomatic, paroxysmal atrial fibrillation (AFib).
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 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).
4 Predictability is determined by the standard deviation of the procedure time.


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SOURCE CardioFocus, Inc.