Published on March 18, 2010 at 4:47 AM
Medtronic, Inc. (NYSE: MDT) today announced it has completed Pre-Market
Approval (PMA) submission in consideration for U.S. Food and Drug
Administration (FDA) approval for the Medtronic Arctic Front®
Cardiac CryoAblation Catheter System, which is designed for patients
with paroxysmal atrial fibrillation (PAF), an irregular quivering of the
upper chambers of the heart that starts and stops on its own. Atrial
fibrillation (AF) is the most common heart arrhythmia in the United
States, with an estimated three million patients suffering from this
condition.
The PMA submission includes data from the STOP AF (Sustained Treatment
of Paroxysmal Atrial Fibrillation) pivotal clinical trial recently
presented Monday, March 15 at the 59th Annual Scientific
Session of the American College of Cardiology. The clinical trial
evaluated the safety and effectiveness of the Arctic Front Cryocatheter
System compared to anti-arrhythmic drug therapy.
Source Medtronic