FDA Update: Updated Use Instructions For Boston Scientific POLARx Cryoablation Ballon Catheters – American College of Cardiology
The U.S. Food and Drug Administration (FDA) has announced that Boston Scientific Corporation is updating use instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters, emphasizing the risk of esophageal fistula and best practices to minimize risk. These updates come following a higher than anticipated number of reports of esophageal injury, specifically atrio-esophageal fistula, after catheter ablation procedures for atrial fibrillation. Keywords: ACC Advocacy, United States Food and Drug
