FDA accepts CardioFocus' premarket application for endoscopically guided laser catheter

The FDA has accepted CardioFocus' (Marlborough, MA) premarket approval application for the company's HeartLight Endoscopic Ablation System (EAS) that treats atrial fibrillation (AF). The accepted application includes safety and effectiveness data from the company's multi-center HeartLight Pivotal Clinical Trial, a randomized, controlled study in which a total of 353 patients were treated at 19 leading arrhythmia centers across the U.S.

The HeartLight system allows surgeons to see what they are ablating inside the heart, according to Dr. Vivek Y. Reddy, senior author, co-principal investigator of the HeartLight U.S. pivotal trial, and Professor of Medicine and Director of Cardiac Arrhythmia Services at the Mount Sinai School of Medicine (New York, NY). Results from the clinical trial found that with increased operator experience, there was a significant improvement in fluoroscopy time and non-significant trends to improvement in procedure time, efficacy, and safety.

The U.S. clinical trial results add to existing clinical evidence, which includes nearly two dozen independent studies, supporting the HeartLight system. Several EU single-center studies have been published reporting high rates of freedom from AF recurrence measured one year after the performance of a single ablation procedure using the system. To date, the system has helped to treat more than 3000 patients worldwide.

Full results of the clinical trial appear in the Journal of the American College of Cardiology (JACC); for more information, please visit http://dx.doi.org/10.1016/j.jacc.2015.07.036.

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