October 27th Circulatory System Devices Panel - Medtronic Ablation Frontiers Cardiac Ablation System of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on December 7, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)

Agenda: On December 7, 2011, the committee will discuss, make recommendations, and vote on information related to a supplement to the premarket approval application (PMA) P010031, sponsored by Medtronic, Inc. Medtronic is requesting FDA approval to expand the indications for use for all commercially available Medtronic Cardiac Resynchronization Therapy Defibrillator (CRT–D) devices covered under PMA P010031. The company has proposed the following expanded indication statement based on the results of the REVERSE and RAFT clinical studies: "Medtronic cardiac resynchronization therapy defibrillator (CRT–D) systems are indicated for heart failure patients who meet the following classification: NYHA Functional Class II who remain symptomatic despite stable, optimal medical therapy, and who have left bundle branch block (LBBB) with a QRS duration ≥120 ms, and leftventricular ejection fraction ≤30%."