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...
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.
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.
7/11/18: The commercial launch follows the country-wide reimbursement approval under Japan's National Health Insurance granted this month and the Japanese Ministry of Health, Labour and Welfare regulatory approval received in July 2017.
CardioFocus, Inc., today announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical studies currently underway. Collectively, up to 1,000 AF patients will be enrolled in these studies. #cardiofocusinc #heartlight®systemforthetreatmentofatrialfibrillation
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