ESTECH Announces FDA Approval to Begin Enrollment in ATTAC-AF IDE Trial for the Treatment of Atrial Fibrillation During Cardiac Surgery
4/3/2012 10:40:57 AM
SAN RAMON, Calif.--(BUSINESS WIRE)--Estech, a leader in minimally invasive and endoscopic cardiac ablation, announced today that the Food and Drug Administration (FDA) has given conditional Investigational Device Exemption (IDE) approval to initiate patient enrollment in the Estech-sponsored ATTAC-AF trial. The IDE trial has been designed to evaluate the treatment of atrial fibrillation (AF) utilizing temperature-controlled radiofrequency (TCRF) ablation in patients undergoing cardiac surgery. Up to 15 centers in the United States and Europe will participate in the trial, which is intended to enroll over 100 cardiac surgery patients.