Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Committee Meeting April 25th from 8:00 a.m. to 6:00 p.m. (Day 1 of 2)

Agenda: On April 25, 2012, the committee will discuss, make recommendations and vote on information related to a supplement to the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS) sponsored by HeartWare, Inc. The HVAS is an implantable electrically powered centrifugal-flow rotary blood pump with external driver and power source(s). It is the first ventricular assist device that does not require the creation of an abdominal pump pocket. The HVAS is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory, advanced heart failure.