FDA approves Medtronic catheter system
Medical device maker Medtronic Inc. said Friday the Food and Drug Administration approved its Arctic Front Cardiac CryoAblation Catheter system to treat a form of atrial fibrillation in patients who do not respond to drug therapy.
Atrial fibrillation causes the upper chambers of the heart to contract irregularly, potentially triggering a stroke. The catheter helps stop the rapid beating of the heart's upper chambers by delivering a coolant that blocks conduction pathways that trigger atrial fibrillation. It is inserted through an artery in the groin and then threaded up to the heart.
Medtronic said regulatory approval was based on a study that showed about 70 percent of patients treated with Arctic Front were free from atrial fibrillation a year later, compared to 7 percent of patients treated only with drug therapy.
The system already is approved in Europe, and a Medtronic spokeswoman said the company plans to start U.S. sales in the next few weeks.
Shares of Medtronic climbed 95 cents, or 2.6 percent, to $37.13 in afternoon trading.