J&J Catheter the First OK’d for Deadly Heart Rhythm

The U.S. Food and Drug Administration has approved a catheter made by Johnson & Johnson that treats a dangerous heart defect afflicting millions of patients in the United States.
 
FDA approved Navistar Thermocool catheters to treat atrial fibrillation, which makes the upper chambers of the heart contract irregularly.
 
About 2.2 million adults in the U.S. have the condition, which makes up about 15 percent of strokes, according to the American Heart Association.
 
“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.

While the heart problem is often linked with stroke, FDA stressed there is no evidence that treatment with the catheter would reduce a patients’ risk of stroke.