FRIDAY, Dec. 17, 2010 (HealthDay News) -- Medtronic's Arctic Front Cardiac CryoAblation Catheter system has been approved by the U.S. Food and Drug Administration to treat atrial fibrillation, the company said in a news release.
Atrial fibrillation, an erratic heartbeat, is the most common heart rhythm disorder in the United States, affecting some 3 million people, the company said. Medtronic also noted that about 40 percent don't have symptoms and may be under-diagnosed.
The newly approved device isolates the pulmonary vein, the source of errant electrical signals that cause the problem, Medtronic said. The device delivers a coolant via an inflated balloon that freezes tissue and stops the conduction of atrial fibrillation.
Clinical studies showed that about 70 percent of people treated with the Arctic Front system no longer had atrial fibrillation after one year, compared with 7.3 percent of patients treated only with drug therapy, the company said.
To learn more about atrial fibrillation, visit the U.S. National Heart Lung and Blood Institute.