Device Dossier

HeartMate 3 LVAS Implant Kit Model 106524INT - Implantable ventricular circulatory assist system

Device Dossier for HeartMate 3 LVAS Implant Kit Model 106524INT - Implantable ventricular circulatory assist system (Implantable ventricular circulatory…

Intended purpose

The HeartMate 3 Left Ventricular Assist System is intended to provide long term haemodynamic 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 3 is intended for use inside or outside the hospital.

Functional description

The LVAS features a blood pump intended for long-term implantation and an extracorporeal System Controller. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology.

TGA Public Summary