HeartMate 3 System Controller Low Flow 2.0 model 106531LF2 - Circulatory assist system, supply unit, external

Intended purpose

The HeartMate III Left Ventricular Assist System is intended to provide long term hemodynamic support in patients with advanced, refractory left ventricular heart failure. It is intended either for temporary support, such as a bridge to cardiac transplantation (BTT), or as permanent destination therapy (DT). The HeartMate III is intended for use inside or outside the hospital.

Functional description

The System Controller Low Flow 2.0 is a small computer that controls and monitors the LVAS operation. It is an extracorporeal interface device that receives power from the Power Module, the Mobile Power Unit or portable Batteries. It appropriately delivers power to the implanted pump via a Driveline that connects the Pump to the System Controller. The System Controller uses lights, sounds, and on-screen messages to communicate with users about operating status and alarm conditions.