People suffering from atrial fibrillation now have another way of treatment offered by California-based BioSense Webster, a Johnson & Johnson company.

 

The company’s Navistar ThermoCool saline irrigated radio-frequency ablation catheter and the EZ Steer ThermoCool Nav were approved by the Food and Drug Administration to treat atrial fibrillation, a form of arrhythmia that affects more than 2 million people in the United States, according to the National Institutes of Health.

 

The condition can be treated with blood thinning medication and in certain severe cases, with open heart surgery. The new catheter approved by the FDA on Friday is meant to be used when drug treatment hasn’t succeeded.

 

“This approval provides physicians with another option for treating this common and potentially debilitating condition,” said FDA's director for medical devices, Dr. Daniel Schultz.

 

NaviStar ThermoCool and EZ Steer ThermoCool Nav are the first minimally invasive tools to ablate the cells that trigger atrial fibrillation. The approval is seen as having “a lot of potential, since there’s no pharmaceutical product out there right now that addresses a-fib particularly well,” Aaron Vaughn, an Edward Jones & Co. analyst in St. Louis, said.

 

The catheters work by burning, freezing or otherwise destroying the malfunctioning heart cells that cause atrial fibrillation.

 

The approval follows studies conducted by BioSense Webster, which showed 62.7 percent of patients treated with the catheter were free from fibrillation symptoms nine months after treatment, compared with 17.2 percent of those taking traditional drug therapy.

 

St. Paul-based St. Jude Medical is planning to market similar devices.