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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.

CardioFocus® Treats First Patients With HeartLight® Endoscopic Ablation System In France

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.

CardioFocus Launches 100th HeartLight® Center Worldwide

"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."

HeartLight® X3 System For The Treatment Of Atrial Fibrillation Receives CE Mark Approval

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.

Persistent Atrial Fibrillation Study With The Breakthrough HeartLight® X3 System

3/5/19: The 60 patient, HeartLight® X3 System prospective study will be led by Na Homolce Hospital in Prague, Czech Republic.

CardioFocus® Announces Full Commercial Launch of HeartLight® System in Japan

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.