Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on October 27 2011, from 8 a.m. to 6 p.m. (Day 2 of 2]

Agenda: On October 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Medtronic Ablation Frontiers Cardiac Ablation System sponsored by Medtronic, Inc. The Medtronic Ablation Frontiers Cardiac Ablation System is a catheter-based device developed for the treatment of atrial fibrillation. The system consists of the following: The Pulmonary Vein Ablation Catheter, which is designed to create lesions in the left atrium via five pairs of electrodes to isolate the pulmonary veins. It has a deflectable distal end and bidirectional steering to aid in positioning the catheter appropriately. The Multi-Array Septal Catheter, which is designed to create lesions on the septal wall of the left atrium via six pairs of electrodes. It is not steerable and is intended to be used in a transseptal approach. The Multi-Array Ablation Catheter, which is designed to create ‘‘X’’-like lesions in the left and/or right atrium via four pairs of electrodes. It has a deflectable distal segment and bidirectional steering within a single plane.