HVAD Controller - Circulatory assist system, supply unit, external

Intended purpose

The HeartWare Controller is an external component of the HeartWare Ventricular Assist System (HVAD®) intended for the treatment of heart failure. It is a microprocessor unit that controls and manages HVAD Pump operation. It is non-sterile and single patient use.

Functional description

The external controller connects to the percutaneous driveline and operates the internal pump. The controller sends and regulates power and operating signals to the pump and collects information from the pump, displays real time pump parameters, as well as alarm conditions. It connects to mains electricity (AC-powered) and/or rechargeable batteries. The controller interfaces with the monitor through a data port.