CardioFocus Reports 10,000+ Patients Worldwide Have Been Treated with the HeartLight® Endoscopic Ablation System
December 15, 2020 CardioFocus 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...
CardioFocus Announces Initial Commercial Procedures Following FDA Approval of HeartLight® X3 Ablation System for Treatment of Atrial Fibrillation
The HeartLight X3 System received U.S. Food and Drug Administration (FDA) approval for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF) in May.
CardioFocus Announces US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation
Approval of the HeartLight X3 System came as a result of a comprehensive submission, including outcomes from the study of 60 HeartLight X3 patients. In this pivotal confirmatory study, the X3 System achieved very rapid pulmonary vein isolation (PVI), in as few as three minutes for a single pulmonary vein.
CardioFocus Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System
The HeartLight X3 System is a next-generation AFib ablation technology, building upon the advanced features of the HeartLight Endoscopic Ablation System.
To date, more than 7,000 patients have been successfully treated in the U.S., Europe and Japan, with the HeartLight System. Within Europe, France is one of the three largest markets for AFib ablation technologies.
"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."
3/25/19: The HeartLight X3 System is a third generation technology building upon the advanced features of the HeartLight Endoscopic Ablation System, which performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib.
3/5/19: The 60 patient, HeartLight® X3 System prospective study will be led by Na Homolce Hospital in Prague, Czech Republic.
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