FDA approves HeartLight Endoscopic Ablation System for patients with paroxysmal atrial fibrillation- CardioFocus

The FDA has approved the HeartLight Endoscopic Ablation System, from CardioFocus, for the treatment of patients with paroxysmal atrial fibrillation (AF). The approved PMA submission contained comprehensive safety and effectiveness data from the Company's multi-center HeartLight U.S. Pivotal Clinical Study, a randomized, controlled study in which a total of 353 participants were randomized at 19 leading arrhythmia centers across the United States.

Results from the pivotal trial, announced at Heart Rhythm 2015, showed that when performing a single ablation procedure using the HeartLight System, the majority of patients experienced freedom from paroxysmal AF at 12 months. In addition, both the primary safety and efficacy endpoints were met.