The U.S. Food and Drug Administration has approved the first ablation catheters for the treatment of atrial fibrillation (uncoordinated contractions of the upper heart chambers), one of the most common types of arrhythmias-or abnormal heart rhythms--affecting more than two million Americans.
The devices approved today, the NaviStar ThermoCool saline irrigated radio-frequency ablation catheter and the EZ Steer ThermoCool Nav, can be used to create small, strategically placed scars in heart tissue to block irregular electrical waves that cause atrial fibrillation. The FDA previously approved other ablation catheters to treat arrhythmias such as atrial flutter and ventricular tachyarrhythmia, but not atrial fibrillation.
Atrial fibrillation is usually treated with drugs, and in certain severe cases, with open heart surgery. Catheter ablation should be used only after drug treatment has failed to adequately control the symptoms of the condition.
"This approval provides physicians with another option for treating this common and potentially debilitating condition," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health.
While atrial fibrillation is a major risk factor related to stroke, there is no conclusive evidence that links the treatment of symptoms by ablation to a reduction in stroke. Therefore, the FDA agrees with the American College of Cardiology, the American Heart Association and the European Society of Cardiology, which recommend that patients at risk for stroke continue to take blood-thinning medications after ablation procedures for atrial fibrillation.