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Medtronic completed Pre-Market Approval (PMA) submission to FDA for Arctic Front Cardiac Cryoablation Catheter System

Medtronic , Inc. announced it has completed 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.

Caution: The Medtronic Arctic Front Cardiac CryoAblation Catheter System is investigational and not currently available for sale in the United States. The device is limited by federal law to investigational use only.

Source: Medtronic