HeartMate 3 System Controller - Circulatory assist system, supply unit, external

Intended purpose

The HeartMate 3 System Controller is a component within a Left Ventricular Assist System (LVAS) that is intended to provide long term haemodynamic support to patients with advanced, refractory left ventricular heart failure. The HeartMate 3 System Controller is the primary user interface that controls and checks system function and connects the implanted pump to the external power sources. The LVAS is intended either for temporary support, such as a bridge to cardiac transplantation (BTT), or as permanent destination therapy (DT).

Functional description

The System Controller 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.