FDA to Review Cryoablation System for Treatment of Paroxysmal AF
March 18, 2010 — A cardiac cryoablation catheter system designed for patients with paroxysmal atrial fibrillation (PAF) has completed premarket approval and is under review by the U.S. Food and Drug Administration (FDA).
PAF is 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 premarket approval submission includes data from the STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial presented last week at the 59th Annual Scientific Session of the American College of Cardiology (ACC). The clinical trial evaluated the safety and effectiveness of the Medtronic Arctic Front Cryocatheter System compared to anti-arrhythmic drug therapy.
The system is investigational and not currently available for sale in the United States. The device is limited by federal law to investigational use only.
For more information: www.medtronic.com