AtriCure gets US approval for first AF ablation device
This article was originally published in Clinica
Executive Summary
AtriCure's Synergy ablation system has received premarket approval (PMA) from the US FDA for the treatment of atrial fibrillation (AF). The decision makes the product the first of its kind to be approved in the US specifically for this indication. Cardiac surgeons there already use ablation devices for AF, but on an off-label basis.