Abbott has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its in-development fully implantable heart pump system.
The US-based medical device company said left ventricular assist devices are currently implanted into the body and powered using an external battery pack or charging port.
Abbott’s fully implantable device would need no external components, giving an advanced option for the patient.
The fully implantable left ventricular assist system (FILVAS) is in the research and development stage. At present, the system is not available for sale in any region across the world.
Abbott’s electrophysiology and heart failure division senior vice president Michael Pederson said: “As the leader in heart failure management, a fully implantable heart pump has been our vision for the tens of thousands of people who progress into advanced heart failure each year.
“The potential for a fully implantable system would mean more freedom and a greater quality of life because there are no external components to be carried everywhere. These advances underscore Abbott’s long-standing commitment to develop innovative devices that allow those with heart failure to live their best lives.”
Abbott’s heart failure portfolio also includes solutions such as the CardioMEMS HF System, quadripolar pacing technology, MultiPoint pacing technology, and others.
Abbott is currently developing the CE Marked and FDA-approved HeartMate 3 LVAD heart pump for advanced heart failure patients who are awaiting transplantation or are not candidates for transplantation.
The company claims it as the first approved LVAD with full MagLev technology, which enables the device’s rotor to be suspended by magnetic forces. It aims to reduce trauma to blood passing via the pump and enhance outcomes for patients.