FDA Approves Ablation Catheters for Afib

The first ablation catheters for the treatment of atrial fibrillation have been approved by the FDA.

15 feb 2009--Ablation catheters have previously been approved to treat other arrhythmias, including atrial flutter and ventricular tachyarrhythmia. The approved devices, manufactured by BioSense Webster, are the NaviStar ThermoCool saline irrigated radio-frequency ablation catheter and the EZ Steer ThermoCool Nav.

In an international study of some 170 patients, 63% treated with the devices were free of atrial fibrillation after 1 year, compared with 17% in a control group.

LINK(S):

FDA news release (Free)