MARLBOROUGH, Mass., March 5, 2019 /PRNewswire/ -- CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced the first enrollments in a clinical study evaluating use of the HeartLight X3 System in an early persistent AFib patient population. The 60 patient, prospective study will be led by Na Homolce Hospital (NHH) in Prague, Czech Republic.
AFib, the most common type of cardiac rhythm disorder,1 is a progressive disease. If left untreated, patients suffering from paroxysmal AFib, with symptoms that come and go, will likely develop persistent AFib, a condition where the heart can no longer regulate its rhythm, with symptoms lasting longer than a week.
"We've used the HeartLight System since its inception, treating more than 500 patients and have seen first-hand the benefits it provides to AFib patients who suffer from this debilitating condition," said Petr Neužil, MD, PhD, Head of the Department of Cardiology at NHH. "As the first center to use the HeartLight X3 System, we've been encouraged by the initial patient outcomes and are thrilled to initiate the evaluation of this next-generation device as a treatment for persistent AFib patients."
For patients with paroxysmal AFib, pulmonary vein isolation (PVI) is a gold-standard catheter ablation treatment strategy and use of a PVI-only treatment approach for early persistent AFib has become progressively more common. The initial outcomes with the HeartLight System in the treatment of persistent AFib through a PVI-only approach have been encouraging:
- A recent randomized multicenter study assessing the outcome of PVI in patients with persistent AFib concluded that PVI with the HeartLight System demonstrated similar efficacy to wide-area circumferential PVI using irrigated radio frequency ablation (RF).
- As part of the study, researchers found that 71.2 percent of patients treated with the HeartLight System experienced freedom from AFib between 90 and 365 days after a single ablation, compared to 69.3 percent in the RF ablation group.2
PVI with the HeartLight X3 System utilizes laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib. Building upon the advanced features of the current HeartLight System – direct tissue visualization, titratable laser energy, and compliant balloon technology – the HeartLight X3 System is designed to deliver quick, continuous, circumferential lesions. The system's unique RAPID mode leverages a precise motor control system that enables uninterrupted, high-speed lesion creation under direct control of the physician resulting in consistently reduced procedure times.
Throughout the recently completed paroxysmal AFib clinical evaluation, the HeartLight X3 System consistently achieved very rapid PVI, in as few as three minutes for a single pulmonary vein. Data from that study will be used to obtain regulatory approvals, with European CE Mark expected by mid-2019.
"We are grateful for our continued partnership with Dr. Neužil and his team at NHH, a leading cardiac center and global innovator," said Burke T. Barrett, President and Chief Operating Officer at CardioFocus. "Our mutual commitment to continue the advancement of the HeartLight platform will bring breakthrough treatment options such as the X3 System to greater numbers of AFib patients around the world."
The HeartLight X3 System is an investigational device and not available for sale.
About Na Homolce Hospital
Accredited by JCI (Joint Commission International), Na Homolce Hospital is one of the top hospitals in Europe and focuses on the comprehensive treatment of cardiovascular and neurological/neurosurgical diseases. Within the cardiovascular specialization, NHH offers the largest range of modern and clinically verified diagnostics and treatments, including conservative treatment, minimally-invasive techniques and surgical procedures on the heart and blood vessels. Its cardiology centers includes those for the treatment of cardiac rhythm disorders, chronic heart failure, congenital heart defects, aortic disease, and valvular heart disease as well as robotic cardiac and vascular surgery.
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 company's FDA-approved HeartLight Endoscopic Ablation System has successfully treated more than 6,000 patients in the United States, Europe and Japan. In 2018, the company introduced the next-generation Excalibur Balloon™, the first FDA-approved ultra-compliant balloon indicated for paroxysmal AFib ablation. Excalibur leverages the proven universal balloon design of the company's HeartLight System and introduces an advanced feature set that optimizes the speed and magnitude of target tissue contact during AFib ablation procedures. The HeartLight System with the Excalibur Balloon is a revolutionary catheter ablation technology that along with direct visualization and titratable laser energy, represents a new standard for AFib ablation. CardioFocus is headquartered in Marlborough, MA. For more information, visit www.CardioFocus.com.
1 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.
2 Circ Arrhythm Electrophysiol. 2017;10:e005767. DOI: 10.1161/CIRCEP.117.005767
SOURCE CardioFocus, Inc.