ARTICLE | Clinical News
Synergy Ablation System regulatory update
January 2, 2012 8:00 AM UTC
FDA approved a PMA for AtriCure's Synergy Ablation System to treat atrial fibrillation (AF) during open-heart concomitant coronary artery bypass grafting and/or valve replacement or repair procedures. AtriCure is required to conduct a post-approval study to evaluate clinical outcomes through 36 months post-operation in 350 patients. The approval also includes a physician training program. ...