First Ablation Catheters Approved for Atrial Fibrillation

FRIDAY Feb. 6, 2009 -- The first ablation catheters to treat a common form of abnormal heartbeat known as atrial fibrillation have been approved by the U.S. Food and Drug Administration.

Atrial fibrillation is among the most frequently diagnosed forms of arrhythmia, the medical term for an abnormal heartbeat. Affecting more than 2 million Americans, atrial fibrillation occurs when irregular electrical waves cause an uncoordinated contraction of the heart's upper chambers.

The Navistar ThermoCool saline irrigated radio-frequency ablation catheter and the EZ Steer ThermoCool Nav are designed to create small scars strategically placed in heart tissue in order to block these irregular electrical waves.

Up to now, atrial fibrillation had been treated with medication, and in certain severe cases, with open heart surgery, the FDA said in a news release. The newly approved catheters are meant to be used when drug treatment hasn't succeeded.

Approval of the devices was based on a study of 167 people at 19 medical centers in five countries. Results showed the devices were effective in eliminating atrial fibrillation for one year in 63 percent of patients, compared with 17 percent of people in a control group, the FDA said.

Both devices are made by California-based BioSense Webster, a Johnson & Johnson company.

Posted: February 2009


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