FDA OKs fibrillation ablation catheters

WASHINGTON, Feb. 9 (UPI) -- The U.S. Food and Drug Administration says it has approved the first ablation catheters designed for the treatment of atrial fibrillation.

Atrial fibrillation -- uncoordinated contractions of the upper heart chambers -- is one of the most common types of arrhythmias, affecting more than 2 million Americans, the FDA said.

The federal agency said the devices approved are the NaviStar ThermoCool saline-irrigated, radio-frequency ablation catheter and the EZ Steer ThermoCool Nav. They can be used to create small, scars in heart tissue to block irregular electrical waves that cause atrial fibrillation.

The FDA said it has previously approved other ablation catheters to treat arrhythmias such as atrial flutter and ventricular tachyarrhythmia, but not atrial fibrillation.

"This approval provides physicians with another option for treating this common and potentially debilitating condition," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.

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