The approval has labelled HeartMate 3 as a destination therapy for people who are not eligible for a transplant.
LVADs are designed to pump blood through the body in order to significantly cut down the workload on a weakened heart. They are said to offer life-saving support for patients with heart failure.
The HeartMate 3 system is comprised of an LVAD pump along with an external, wearable controller and battery system. The pump leverages the Full MagLev Flow technology that minimises trauma to blood passing through it and improves flow.