Ablation Catheter Approved for Atrial Fibrillation

The FDA has approved BioSense Webster’s NaviStar ThermoCool and EZ Steer ThermoCool Nav for the treatment of atrial fibrillation. The devices are intended to be used when drug therapy fails. The company must establish a physician training program and conduct postmarketing studies to collect data on the products’ long-term safety and effectiveness as part of a condition of the device approvals, according to an FDA statement.