Abbott has secured approval from the US Food and Drug Administration (FDA) for the use of its HeartMate 3 Left Ventricular Assist Device (LVAD) for advanced heart failure patients.
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 FDA approval is based on results obtained during the 1,000-patient MOMENTUM 3 clinical trial, where participants with Abbott’s new LVAD had an 82.8% survival rate at two years.”
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.
Abbott Cardiac Arrhythmias and Heart Failure business senior vice-president Mike Pederson said: “The unique design of the HeartMate 3 LVAD, with its Full MagLev Technology, takes an established innovation and improves upon it in meaningful ways to help people with advanced heart failure live fuller lives.”
The FDA approval is based on results obtained during the 1,000-patient MOMENTUM 3 clinical trial, where participants with Abbott’s new LVAD were found to have an 82.8% survival rate at two years.
In addition, HeartMate 3 patient group had low rates of suspected pump thrombosis of 1.1% at two years. The device is also reported to have led to low stroke rate (10%).
Abbott focuses on the development of minimally invasive diagnostics and medical technologies to help people with cardiovascular conditions.
Last month, the company received the European CE-Mark for Architect Stat High Sensitive Troponin-I blood test to predict the risk of a heart attack or other cardiac events in seemingly healthy people.