The US Food and Drug Administration on Friday approved Johnson & Johnson’s Navistar Thermocool catheters to treat atrial fibrillation.

 

Atrial fibrillation can lead to palpitations, fainting, fatigue or congestive heart failure. It can also lead to blood clots and stroke. The condition becomes more common with age. About 1 in 100 people, and nearly 9 in 100 over the age of 80 have atrial fibrillation.

 

Some 70,000 Americans a year have embolic strokes, which can be caused by atrial fibrillation where the blood "pools" and sometimes clots in the atria (chambers of the heart), from which a piece breaks off and causes the stroke.

 

Atrial fibrillation had been 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.

 

The approval follows studies conducted by Diamond Bar, Calif.-based Biosense Webster, a unit of Johnson & Johnson, 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.

 

The Navistar Thermocool catheter was previously cleared to treat atrial flutter, a less severe type of heart problem. It works by creating small scars using extreme heat which are strategically placed in heart tissue to block the nerve signals that cause irregular contractions.

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