CardioFocus’ HeartLight Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation (AF), the irregular rhythm of the heart, has received premarket approval from the FDA.

Unlike other AF solutions that rely on X-ray or mapping support, HeartLight allows the clinician to control the delivery of laser energy under direct endoscopic visualization. The system isolates the pulmonary veins with a balloon catheter that accommodates different pulmonary vein anatomies.

The submission to the FDA contained information about safety and data from CardioFocus’ multi-center HeartLight U.S. pivotal clinical study, a randomized, controlled study of 353 patients. When clinicians used the HeartLight system to perform a single ablation procedure, an invasive technique that removes or melts away unwanted tissue, the majority of patients did not have paroxysmal AF at twelve months.
Dr. Vivek Y. Reddy, co-principal investigator, director of cardiac arrhythmia services for The Mount Sinai Hospital, and The Helsmley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and the team, were able to use the control arm device for both pulmonary vein isolation and other left atrial regions, with up to two control arm procedures allowed.

“This was a large study and the device clearly met both primary safety and efficacy endpoints. I am confident these results, produced by physicians who were new to the laser balloon, demonstrate the promise of the HeartLight technology in routine clinical use,” said co-principal investigator Dr. Andrea Natale, executive medical director at the Texas Cardiac Arrhythmia Institute, Center for Atrial Fibrillation at St. David's Medical Center, in a statement.

There have been dozens of independent studies supporting the CardioFocus HeartLight system, according to the study, and several European single-center studies have reported high rates, of up to 80 percent, of freedom from AF recurrence measured one year or more after the performance of a single ablation procedure.

The learning curve of the HeartLight system is very short, said Dr. Frank Cuoco, the fellow of the American College of Cardiology Associate Professor of Medicine, Division of Cardiology at the Medical University of South Carolina in Charleston, SC, in a statement.

“I am confident that this new laser balloon catheter will offer our patients an outstanding treatment option for atrial fibrillation,” he added. To date, more than 3,400 patients worldwide has been treated using the HeartLight system.

CardioFocus is finalizing preparations to commercialize the HeartLight System in the U.S.

AF is the most common type of heart arrhythmia and affects an estimated 2.7 to 6.1 million people in the U.S, according to the CDC. Additionally, AF contributes to an estimated 130,000 deaths each year.

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