First Ablation Catheters for Atrial Fibrillation Treatment Approved by FDA


Friday, the U.S. Food and Drug Administration approved the first ablation catheters for the treatment of atrial fibrillation.

Atrial fibrillation is uncoordinated contractions of the upper heart chambers. It is one of the most common types of arrhythmias - or abnormal heart rhythms--affecting more than two million Americans.

The devices approved, 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 has previously approved other ablation catheters to treat arrhythmias such as atrial flutter and ventricular tachyarrhythmia.


Atrial fibrillation is usually treated with drugs. Catheter ablation is used after drug treatment has failed to adequately control the symptoms of the condition.

The FDA based this approval on a clinical study of 167 patients at 19 medical centers in the United States, Brazil, Canada, the Czech Republic, and Italy. Data from the study showed the devices to be effective in eliminating symptomatic recurrence of atrial fibrillation episodes for one year in approximately 63 percent of treated patients versus 17 percent of the patients in the control group.

As a condition of approval, manufacturer BioSense Webster must establish a physician training program and conduct postmarket studies to collect data on these devices' long-term safety and effectiveness (including incidence of stroke, mortality, cardiac arrest, major bleeding, and pulmonary vein stenosis), and the effect of physicians' experience in operating the device on procedural safety.

Both catheters are manufactured by BioSense Webster of Diamond Bar, Calif.

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